Regulatory Review & Approval

Full Compliance According to FDA – Standards & Guidelines

FDA Approved

Every product that is manufactured at our facility is either an FDA approved, pending under review or dietary supplement product. Our FDA consultants are highly knowledgeable and experienced in the areas of pharmaceutical governance & compliance. Below are some of the services we offer for regulatory review & approval:

  1. Submission Filings for NDAs & ANDAs
  2. Regulatory Review on OTC & Rx products for FDA manufacturing approval
  3. Regulatory Review & Approval on Artwork Designs and Labels
  4. Regulatory consulting on using combined Active Ingredients
  5. Regulatory Review on product classifications

Additionally, our rates are very competitive, and most importantly, you won’t have to worry about the FDA recalling your product due to mislabeling claims or deceptive marketing!

5 Reasons You Need Regulatory Review & Approval:
  1. Avoid Mislabel Claims or Deceptive Marketing
  2. Avoid Recalling of your products by the FDA
  3. Be fully in compliance according to FDA Standards & Guidelines
  4. Get labels approved by licensed lawyers or regulatory consultants
  5. Make sure your labels and NDCs will be allowed for registrations within the State and FDA
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