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; 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 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; Business consulting and for companies in the life sciences fields for use in the following applications: supply chain management; including, 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; 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; Business consulting and management for companies in the life sciences fields for use in the following applications: compliance strategy: including 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 strategy, including: support on demand services, development on demand services; Business consulting and management for companies in the life sciences fields for use in the following applications: management; including life sciences and program management, GxP cloud services, and organizational change management; Providing quality and IT staffing solutions for companies in the life sciences fields, including staffing augmentation services and onsite and remote on-demand compliance staff augmentation; Business consulting and management for companies in the life sciences fields for use in the following applications: enterprise systems; including enterprise content management, cloud-based data migration, quality document management systems, enterprise quality management, learning management systems, and electronic lab notebooks

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; 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

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; Consulting services in the field of cloud computing in the field of life science; 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; Technical and scientific consulting and management for companies in the life sciences fields for use in the following applications: enterprise systems; including 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; 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; Technical and management for companies in the life sciences fields for use in the following applications: supply chain management; including, 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; 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; Technical and scientific consulting and management for companies in the life sciences fields for use in the following applications: compliance strategy: including 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 applications: digital transformation strategy, including: support on demand services, development on demand services; Technical and scientific consulting and management for companies in the life sciences fields for use in the following applications: management; including life sciences and program management, GxP cloud services, and organizational change management (OCM)