Regulatory Affairs

Regulatory affairs professionals are involved in product development from the beginning.

Regulatory restraints and requirements will be considered when drafting the pharmaceutical, preclinical and clinical development plan. Development targets and key claims will be reviewed and adapted to regulatory guidelines and regulations. Consultations with the appropriate regulatory agencies, e.g. pre-IND meetings with the FDA, are milestones in product development. Regulatory professionals ensure that the information and data to be conveyed and discussed with the regulatory bodies are presented in the appropriate format and manner. They develop the regulatory strategy, arrange agency meetings, prepare and compile the questions and briefing documents; they attend the meetings and manage all communication with the agencies. Since the regulatory environment is constantly changing, the regulatory team provides advice on necessary adaptations to development plans and target product profiles according to published guidelines.

An overview of the FDA approval process is shown in the figure below

*indicates the progression from bench to bedside

Other activities of the LCGM regulatory affairs team will include but are not limited to:

  • Product IND/CMC development: Phase I, Phase II clinical trials
  • FDA submittals/communications (INTERACT; Type B Meetings; Type C meetings, as needed)
  • IND Annual reporting Support
  • IND Amendments
  • GLP Design for Pre-Clinical Safety studies
  • cGMP Facilities registration/licensing
  • cGMP Facilities auditing and reporting requirements

Click the links below to be connected with the associated FDA process

The National Academies Press; 2017