35 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 quality and 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; 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