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

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