RRegulatory Affairs

FDA (Food and Drug Administration) governs the regulations for Pharmaceutical and Medical Device Industries in USA. Any product, including drug and medical device to enter the market should go through the submission process with FDA via., NDA, ANDA, 510K, PMA (Pre-Market Approval) process. This requires the expertise of a Regulatory Affairs Specialist to create the required evidence for submission. The Documents are prepared based on many countries wherever the product is released including Canada, Japan, China, Europe, India, Australia and many more.

At Revere IT LLC, we

  • Provide Regulatory Expertise on International and Domestic submissions.
  • Prepare documentation for regulatory registrations and submissions, including 510(k)s, PMA, NDA/INDA, ANDA as required.
  • Provide Implementation support of electronic submission database for global submissions to meet requirements of EU e-CTD format.
  • Prepare Standard Operating Procedures for post-market regulatory activities, to meet US, EU, Canada, Japan, China, Australia and many other country Regulatory requirements.
  • Provide support in Regulatory Submissions, Strategy Development, Pre-Market Approvals/Post Market Approvals, CE Marking, Product Registrations etc.