Regulatory Medicine is a component of Regulatory Affairs that serves as an interface between regulatory agencies and medical scientists in the planning, development, production, and provision of cell and gene therapies and medical devices for the treatment of patients in a clinical setting.
- Document Control- Creation of SOPs, policies, forms, product labels, and worksheets in an appropriate format with versioning and archival histories which meet regulatory standards.
- Validations and Verifications- Creation of thorough plans and schedules for the validation and/or verification of equipment, reagents, and processes used in the development, production, and provision of medical therapies and devices.
- Change Control and Qualification- Management of changes needed to processes and materials that can occur during development and production of medical products, as well as making certain that critical materials and supplies are of the appropriate quality for use in patients.
- Audits and Findings- Development of plans for internal and external audits as well as responses to audit findings.
- Product and Test Report Release- Review of reports for release of products and tests as well as creation of documents for the same purpose that meets regulatory standards.
- Training and Competency- Development of plans, documents, and records to ensure successful training and continued competency of staff members, one of the most often overlooked components of a successful product development.
- Issue Resolution- Plans for management of adverse events, investigations into deviations and incidents, and long-term safety follow-up of products and devices.
- Regulatory Authority Interactions- Preparation for and participation in communication with regulatory authorities during meetings and inspections and follow-up.
- Regulatory Authority Strategy and Intelligence- Knowledge of the ever changing regulatory requirements for implementation of successful studies, processes, and products.
Regulatory Authority Submissions- Application of regulatory strategy and intelligence for the preparation of accurate and successful submissions to regulatory agencies.