Regulatory Affairs

Clinical Research Consultants provides strategic planning for new product introduction.  This includes expert planning, management, and preparation of regulatory submissions.

CRC’s comprehensive management services for all aspects of regulatory affairs include:

Developing and Implementing Product-Specific Regulatory Strategies

  • Assess impact of regulatory environment and FDA policies
  • Design pre-clinical and clinical studies
  • Evaluate technical and clinical data
  • Communicate and meet with FDA
  • U.S. Agent/Correspondent

Preparing and Submitting Regulatory documents

  • Investigational device exemption (IDE) applications
  • Premarket notifications [510(k)’s]
  • Premarket approval (PMA) applications
  • RFD, 513(g)
  • HDE and Orphan Drug

Reviewing and Developing Instruction Manuals and Other Labeling for FDA compliance

  • Surgical Manuals
  • Instructions for use (IFUs)
  • Product labeling
  • Literature review for compliance

Providing Liaison with FDA