Our services

Regulatory Affairs Consulting

Annual PMA Submissions

  • Change Application Review
  • Summary and Bibliography Update Review
  • Table of Content Review
  • Summary Review: (Product Description, Alternative Practices and Procedures, Marketing History, Study Summaries and Conclusions)
  • Product Description Review
  • Reference of Performance or Voluntary Standards Review
  • Nonclinical Lab Results Review
  • Clinical Investigations Involving Humans Review
  • Bibliography Review
  • Proposed Labeling Review
  • Environmental Assessment Review
  • Financial Certification and Disclosure Statement Consulting
  • Cover Letter Review

Our brands and projects