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Description:
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(1) - Business advisory, development, and strategic planning services provided to companies for business purposes in the life sciences industries; Business consultation services in the field of GxP (Good Practice) compliance; Business consulting services on processes and workflows related to content creation, localization and publishing strategy including Translation Memory and Terminology Management, Quality Management, Life Sciences Regulatory Compliance and Risk Management; Business consulting and management in the field of clinical trials, namely, clinical data and regulatory submission management on behalf of medical, biopharmaceutical and biotechnology companies to assist them with clinical research, clinical trials and applications for drug approval; Regulatory submission management, namely, assisting others in preparing and filing applications for new medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology with governmental regulatory bodies around the world; Regulatory submission management, namely, providing simultaneous multiple country submissions of applications for the registration and approval of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; providing information online regarding regulatory submission management; Business management consulting, strategic planning and business advisory services provided to medical, medical technology, biopharmaceutical, and biotechnology companies, and government agencies, educational and research institutions, law firms, and investment firms in the fields of biologics, pharmaceuticals and medical devices; Providing consulting services in the field of regulatory submission management to medical companies to assist them with applications for drug and medical device approval; Regulatory submission management, namely, assisting others in preparing and filing applications for new drugs and medical devices with governmental regulatory bodies; Business consulting services in the field of biologics, pharmaceuticals, prescription drugs and medical devices; Business consulting and management for companies in the life sciences fields pertaining to business operations including standard operating procedures, audits and assessments; Business consulting and for companies in the life sciences fields related to supply chain management, including, internet of medical things (IoMT), connected service and quality management, product lifecycle management, product master management, and enterprise resource planning; Providing IT staffing services for companies in the life sciences fields and employment consultation pertaining to staffing augmentation services and onsite and remote on-demand compliance staff augmentation; Business consulting and management for companies in the life sciences fields pertaining to business operations including information and data compiling and analyzing relating to business management; consulting services in the field of medical device product approval for commercial purposes.
(2) - Advisory, development, and strategic planning services provided to companies for business purposes in the life sciences industries; business consultation services in the field of GxP compliance; business consulting services on processes and workflows related to content creation, localization and publishing strategy including Translation Memory and Terminology Management, Quality Management, Life Sciences Regulatory Compliance and Risk Management; business consulting and management in the field of clinical trials, namely, clinical data and regulatory submission management on behalf of medical, biopharmaceutical and biotechnology companies to assist them with clinical research, clinical trials and applications for drug approval; regulatory submission management, namely, assisting others in preparing and filing applications for new medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology with governmental regulatory bodies around the world; regulatory submission management, namely, providing simultaneous multiple country submissions of applications for the registration and approval of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; providing information online regarding regulatory submission management (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); business management consulting, strategic planning and business advisory services provided to medical, medical technology, biopharmaceutical, and biotechnology companies, and government agencies, educational and research institutions, law firms, and investment firms in the fields of biologics, pharmaceuticals and medical devices; providing consulting services in the field of regulatory submission management to medical companies to assist them with applications for drug and medical device approval (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); regulatory submission management, namely, assisting others in preparing and filing applications for new drugs and medical devices with governmental regulatory bodies; business consulting services in the field of biologics, pharmaceuticals, prescription drugs and medical devices; business consulting and management for companies in the life sciences fields for use in the following applications, namely, regulation support, including standard operating procedures, customized compliance training programs, compliance as service (CaaS), medical device cybersecurity, medical device compliance, data integrity, serialization/track and trace, global unique device identification, good clinical practice (GCP) compliance and quality assurance, drug safety, pharmacovigilance (PV), risk-based monitoring, auditing as a service (AaaS), risk management, remediation planning and execution, emerging companies compliance road mapping, EU MDR and IVDR compliance, and audits and assessments (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); business consulting and for companies in the life sciences fields for use in the following applications, namely, supply chain management (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), including, internet of medical things (IoMT), connected service and quality management, product lifecycle management, product master management, and enterprise resource planning (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); business consulting and management for companies in the life sciences fields for use in the following applications: validation and qualification, including, computer software assurance, manufacturing system validation, laboratory equipment and instrumentation, process validation and cleaning validation, laboratory information management systems (LIMS), facilities and utilities, and manufacturing systems (term considered too vague by
(3) - Advisory, development, and strategic planning services provided to companies for business purposes in the life sciences industries; business consultation services in the field of gxp compliance; business consulting services on processes and workflows related to content creation, localization and publishing strategy including translation memory and terminology management, quality management, life sciences regulatory compliance and risk management; business consulting and management in the field of clinical trials, namely, clinical data and regulatory submission management on behalf of medical, biopharmaceutical and biotechnology companies to assist them with clinical research, clinical trials and applications for drug approval; regulatory submission management, namely, assisting others in preparing and filing applications for new medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology with governmental regulatory bodies around the world; regulatory submission management, namely, providing simultaneous multiple country submissions of applications for the registration and approval of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; providing information online regarding regulatory submission management (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); business management consulting, strategic planning and business advisory services provided to medical, medical technology, biopharmaceutical, and biotechnology companies, and government agencies, educational and research institutions, law firms, and investment firms in the fields of biologics, pharmaceuticals and medical devices; providing consulting services in the field of regulatory submission management to medical companies to assist them with applications for drug and medical device approval (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); regulatory submission management, namely, assisting others in preparing and filing applications for new drugs and medical devices with governmental regulatory bodies; business consulting services in the field of biologics, pharmaceuticals, prescription drugs and medical devices; business consulting and management for companies in the life sciences fields for use in the following applications: regulation support; including standard operating procedures, customized compliance training programs, compliance as service (caas), medical device cybersecurity, medical device compliance, data integrity, serialization/track and trace, global unique device identification, good clinical practice (gcp) compliance and quality assurance, drug safety, pharmacovigilance (pv), risk-based monitoring, auditing as a service (aaas), risk management, remediation planning and execution, emerging companies compliance road mapping, eu mdr and ivdr compliance, and audits and assessments (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); business consulting and for companies in the life sciences fields for use in the following applications: supply chain management (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); including, internet of medical things (iomt), connected service and quality management, product lifecycle management, product master management, and enterprise resource planning (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); business consulting and management for companies in the life sciences fields for use in the following applications: validation and qualification; including, computer software assurance, manufacturing system validation, laboratory equipment and instrumentation, process validation and cleaning validation, laboratory information management systems (lims), facilities and utilities, and manufacturing systems (term considered too vague by the Internation
(4) - Advisory, development, and strategic planning services provided to companies for business purposes in the life sciences industries; business consultation services in the field of gxp compliance; business consulting services on processes and workflows related to content creation, localization and publishing strategy namely translation memory and terminology management, quality management, life sciences regulatory compliance and risk management; business consulting and management in the field of clinical trials, namely, clinical data and regulatory submission management on behalf of medical, biopharmaceutical and biotechnology companies to assist them with clinical research, clinical trials and applications for drug approval; regulatory submission management, namely, assisting others in preparing and filing applications for new medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology with governmental regulatory bodies around the world; regulatory submission management, namely, providing simultaneous multiple country submissions of applications for the registration and approval of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; providing online business information regarding regulatory submission management; business management consulting, strategic planning and business advisory services provided to medical, medical technology, biopharmaceutical, and biotechnology companies, and government agencies, educational and research institutions, law firms, and investment firms in the fields of biologics, pharmaceuticals and medical devices; providing business consulting services in the field of regulatory submission management to medical companies to assist them with applications for drug and medical device approval; regulatory submission management, namely, assisting others in preparing and filing applications for new drugs and medical devices with governmental regulatory bodies; business consulting services in the field of biologics, pharmaceuticals, prescription drugs and medical devices; business consulting and management for companies in the life sciences fields for use in the following applications: regulation support, namely standard operating procedures, customized compliance training programs, compliance as service (caas), medical device cybersecurity, medical device compliance, data integrity, serialization/track and trace, global unique device identification, good clinical practice (gcp) compliance and quality assurance, drug safety, pharmacovigilance (pv), risk-based monitoring, auditing as a service (aaas), risk management, remediation planning and execution, emerging companies compliance road mapping, eu mdr and ivdr compliance, and audits and assessments; business consulting and management for companies in the life sciences fields for use in the following applications: supply chain management, namely, internet of medical things (iomt), connected service and quality management, product lifecycle management, product master management, and enterprise resource planning; business consulting and management for companies in the life sciences fields for use in the following applications: validation and qualification, namely, computer software assurance, manufacturing system validation, laboratory equipment and instrumentation, process validation and cleaning validation, laboratory information management systems (lims), facilities and utilities, and manufacturing systems; business consulting and management for companies in the life sciences fields for use in the following applications: compliance strategy, namely laboratory validation, assessments, strategy and remediation planning, performing remediation activities, and providing advisory services to assist gxp labs in meeting commercial and regulatory requirements; business consulting and management for companies in the life sciences fields for use in the following applications: digital transformation s
(5) - Providing educational information and production of customized training materials in the life science fields through various print and electronic multimedia, namely: videos, blogs, articles, webinars, white papers, onsite/offsite remote channels, workshops, hands-on training programs, and other training environments in the life sciences fields, namely but not limited to the following subject matter: regulatory issues and developments, GxP (Good Practice) compliance, risk management, design control, QMS (Quality Management Solutions), CSV (Computer system Validation), SOP (Standard Operating Procedures), data integrity, UDI (Unique Device Identification), regulatory readiness, and other related practice areas in the life sciences fields
(6) - Providing educational programs in the life science fields using on-line activities, non-downloadable webinars and blogs, workshops, and printable materials distributed therewith featuring Regulatory issues and developments, GxP (Good Practice) Compliance, Risk Management, Design Control, QMS (Quality Management Solutions), CSV (Computer System Validation), SOP (Standard Operating Procedures), Data Integrity, UDI (Unique Device Identification), Regulatory readiness, and other related practice areas in the life sciences fields.
(7) - Providing educational and informational content and customized training materials and programs in the life science fields through various print and electronic multimedia, including: videos, blogs, articles, webinars, white papers, onsite/offsite remote channels, workshops, hands-on training programs, and other training environments in the life sciences fields, including but not limited to the following subject matter: regulatory issues and developments; GxP (Good Practice) compliance: risk management (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); design control (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); QMS (Quality Management Solutions) (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); CSV (Computer System Validation) (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); SOP (Standard Operating Procedures) (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); data integrity (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); UDI (Unique Device Identification) (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); regulatory readiness, and other related practice areas in the life sciences fields (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations).
(8) - Providing educational and informational content and customized training materials and programs in the life science fields through various print and electronic multimedia, including, videos, blogs, articles, webinars, white papers, onsite/offsite remote channels, workshops, hands-on training programs, and other training environments in the life sciences fields, including but not limited to the following subject matter, namely, regulatory issues and developments, GxP (Good Practice) compliance,risk management (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), design control (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), QMS (Quality Management Solutions) (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), CSV (Computer System Validation) (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), SOP (Standard Operating Procedures) (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), Data Integrity (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), UDI (Unique Device Identification) (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), regulatory readiness, and other related practice areas in the life sciences fields (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations).
(9) - Consulting services in the fields of biotechnology, pharmaceutical research and development and genetic science; consulting services in the fields of biotechnology, pharmaceutical research and development, quality manufacturing, information technology, and computer aided design; consulting services for others in the field of designing pre-clinical and clinical studies and trials for others; product research and development for others in the fields of biologics, pharmaceuticals, prescription drugs and medical devices; quality management services, namely, quality evaluation and analysis, quality assurance and quality control in the field of biologics, pharmaceuticals, prescription drugs and medical devices; scientific consulting and research services relating to the field of pharmaceuticals, medical devices, and life sciences, namely, biology, and medicine; consulting services in the fields of biotechnology and pharmaceuticals, namely, design, development, technical verification and technical validation of manufacturing and filling processes, drug formulations, testing protocols and analytical methods; and scientific and technological services, namely, scientific research, analysis, testing, and related scientific studies in the field of chemistry and molecular biology, namely, biologics and protein detection, characterization, analysis and testing; consulting services in the field of medical device product approval for commercial purposes (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); consulting services in the field of cloud computing in the field of life science; providing technical regulatory affair consulting services directed to medical, medical technology, biopharmaceutical, and biotechnology companies in order to assure compliance with food and drug administration's laws and regulations (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); technical and scientific consulting and management for companies in the life sciences fields for use in the following applications: enterprise systems (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); including enterprise content management, cloud-based data migration, quality document management systems, enterprise quality management, learning management systems, and electronic lab notebooks (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); technical and scientific consulting and management for companies in the life sciences fields for use in the following applications: regulation support (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); including standard operating procedures, customized compliance training programs, clinical compliance as service (CaaS), medical device cybersecurity, medical device compliance, data integrity, serialization/track and trace, global unique device identification, good clinical practice (GCP) compliance and quality assurance, risk-based monitoring, auditing as a service (AaaS), risk management, remediation planning and execution, emerging companies compliance roadmapping, EU MDR and IVDR compliance, and audits and assessments (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); technical and management for companies in the life sciences fields for use in the following applications: supply chain management (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); including, internet of medical things (IoMT), connected service and quality management, product lifecycle management, product master data management, and enterprise resource planning (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); technical and scientific consulting and management for companies in the life sciences fields for use in the following applications:
(10) - Consulting services in the fields of biotechnology, pharmaceutical research and development and genetic science; biotechnology research consulting services; pharmaceutical research and product development for use in manufacturing; information technology consultation services; computer aided design services; Consulting services for others in the field of designing pre-clinical and clinical studies and trials for others; product research and development for others in the fields of biologics, pharmaceuticals, prescription drugs and medical devices; quality management services, namely, quality evaluation and analysis, quality assurance and quality control in the field of biologics, pharmaceuticals, prescription drugs and medical devices; scientific consulting and research services relating to the field of pharmaceuticals, medical devices, and life sciences, namely, biology, and medicine; design and development and technical verification consulting services in the fields of biotechnology and pharmaceutical research, and scientific and technological services, namely, scientific research, analysis, testing, and related scientific studies in the field of chemistry and molecular biology, namely, biologics and protein detection, characterization, analysis and testing; Computer consulting services in the field of cloud computing in the field of life science; Technical and scientific research consulting and computer project management for companies in the life sciences fields pertaining to cloud-based data migration; Technical and scientific consulting and management for companies in the life sciences fields pertaining to technical verification and validation laboratory equipment and instrumentation; Technical and scientific consulting and management for companies in the life sciences fields for digital purposes, including digital compression of computer data; Technical and scientific consulting and management for companies in the life sciences fields for cloud computing purposes, including GxP (Good Practice) cloud seeding services.
(11) - Consulting services in the fields of biotechnology, pharmaceutical research and development and genetic science; consulting services in the fields of biotechnology, pharmaceutical research and development, quality manufacturing, information technology, and computer aided design; consulting services for others in the field of designing pre-clinical and clinical studies and trials for others; product research and development for others in the fields of biologics, pharmaceuticals, prescription drugs and medical devices; quality management services, namely, quality evaluation and analysis, quality assurance and quality control in the field of biologics, pharmaceuticals, prescription drugs and medical devices; scientific consulting and research services relating to the field of pharmaceuticals, medical devices, and life sciences, namely, biology, and medicine; consulting services in the fields of biotechnology and pharmaceuticals, namely, design, development, technical verification and technical validation of manufacturing and filling processes, drug formulations, testing protocols and analytical methods, and scientific and technological services, namely, scientific research, analysis, testing, and related scientific studies in the field of chemistry and molecular biology, namely, biologics and protein detection, characterization, analysis and testing; consulting services in the field of medical device product approval for commercial purposes (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); consulting services in the field of cloud computing in the field of life science; providing technical regulatory affair consulting services directed to medical, medical technology, biopharmaceutical, and biotechnology companies in order to assure compliance with food and drug administration's laws and regulations (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); technical and scientific consulting and management for companies in the life sciences fields for use in the following applications, namely, enterprise systems (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), including enterprise content management, cloud-based data migration, quality document management systems, enterprise quality management, learning management systems, and electronic lab notebooks (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); technical and scientific consulting and management for companies in the life sciences fields for use in the following applications, namely, regulation support (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), including standard operating procedures, customized compliance training programs, clinical compliance as service (CaaS), medical device cybersecurity, medical device compliance, data integrity, serialization/track and trace, global unique device identification, good clinical practice (GCP) compliance and quality assurance, risk-based monitoring, auditing as a service (AaaS), risk management, remediation planning and execution, emerging companies compliance roadmapping, EU MDR and IVDR compliance, and audits and assessments (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); technical and management for companies in the life sciences fields for use in the following applications, namely, supply chain management (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations), including, internet of medical things (IoMT), connected service and quality management, product lifecycle management, product master data management, and enterprise resource planning (term considered too vague by the International Bureau - Rule 13 (b) of the Regulations); technical and scientific consulting and management for companies in the life sciences fields for use in the
(12) - Consulting services in the fields of biotechnology, pharmaceutical research and development and genetic science; consulting services in the fields of biotechnology, pharmaceutical research and development, quality manufacturing, information technology, and computer aided design; consulting services for others in the field of designing pre-clinical and clinical studies and trials for others; product research and development for others in the fields of biologics, pharmaceuticals, prescription drugs and medical devices; quality management services, namely, quality evaluation and analysis, quality assurance and quality control in the field of biologics, pharmaceuticals, prescription drugs and medical devices; scientific consulting and research services relating to the field of pharmaceuticals, medical devices, and life sciences, namely, biology, and medicine; consulting services in the fields of biotechnology and pharmaceuticals, namely, design, development, technical verification and technical validation of manufacturing and filling processes, drug formulations, testing protocols and analytical methods; and scientific and technological services, namely, scientific research, analysis, testing, and related scientific studies in the field of chemistry and molecular biology, namely, biologics and protein detection, characterization, analysis and testing; consulting services in the field of medical device certification [quality control]; consulting services in the field of cloud computing in the field of life science; providing technological consultancy in the field of medical technology, biopharmaceutical technology, and biotechnology for companies in order to assure compliance with food and drug administration's laws and regulations; technical and scientific consulting and management for companies in the life sciences fields for use in the following applications: enterprise systems, namely enterprise content management, cloud-based data migration, quality document management systems, enterprise quality management, learning management systems, and electronic lab notebooks; technical and scientific consulting and management for companies in the life sciences fields for use in the following applications: regulation support, namely standard operating procedures, customized compliance training programs, clinical compliance as service (caas), medical device cybersecurity, medical device compliance, data integrity, serialization/track and trace, global unique device identification, good clinical practice (gcp) compliance and quality assurance, risk-based monitoring, auditing as a service (aaas), risk management, remediation planning and execution, emerging companies compliance roadmapping, eu mdr and ivdr compliance, and audits and assessments; technical and management for companies in the life sciences fields for use in the following applications: supply chain management, namely, internet of medical things (iomt), connected service and quality management, product lifecycle management, product master data management, and enterprise resource planning; technical and scientific consulting and management for companies in the life sciences fields for use in the following applications: validation and qualification, namely, computer software assurance, manufacturing system validation, laboratory equipment and instrumentation, process validation and cleaning validation, laboratory information management systems (lims), facilities and utilities, and manufacturing systems; technical and scientific consulting and management for companies in the life sciences fields for use in the following applications: compliance strategy, namely laboratory validation, assessments, strategy and remediation planning, performing remediation activities, and providing advisory services to assist gxp labs in meeting commercial and regulatory requirements; technical and scientific consulting and management for companies in the life sciences fields for use in the following
(13) - Regulatory compliance consulting services in the life sciences fields, namely, reviewing standards and practices to assist clients with compliance with governmental laws, regulations and rules pertaining to medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; provision of information online pertaining to regulatory compliance in the fields of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; regulatory compliance consulting in the fields of biologics, pharmaceuticals, prescription drugs and medical devices
(14) - Regulatory compliance consulting services in the life sciences fields, namely, reviewing standards and practices to assist clients with compliance with governmental laws, regulations and rules pertaining to medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; provision of information online pertaining to regulatory compliance in the fields of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; and regulatory compliance consulting in the fields of biologics, pharmaceuticals, prescription drugs and medical devices.
(15) - Regulatory compliance consulting services in the life sciences fields, namely, reviewing standards and practices to assist clients with compliance with governmental laws, regulations and rules pertaining to medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; provision of information online pertaining to regulatory compliance in the fields of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology, and regulatory compliance consulting in the fields of biologics, pharmaceuticals, prescription drugs and medical devices.
(16) - Regulatory compliance consulting services in the life sciences fields, namely, reviewing standards and practices to assist clients with compliance with governmental laws, regulations and rules pertaining to medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; providing technical regulatory affair consulting services directed to medical, medical technology, biopharmaceutical, and biotechnology companies in order to assure compliance with food and drug administration's laws and regulations; provision of information online pertaining to regulatory compliance in the fields of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; and regulatory compliance consulting in the fields of biologics, pharmaceuticals, prescription drugs and medical devices.
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