DOMESTIC REGULATORY AFFAIRS
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