Regulatory Counsel

As an increasing number of regulations continue to characterize the pharmaceutical market, contract manufacturers must be aware of these changes to ensure a high success rate throughout the submission process. At Sterling Pharmaceutical, we are aware of these regulatory standards and have aligned our manufacturing process to match these.  

Whether the product for submission is a new drug entity or an existing drug that requires corrections or changes to be made, we assure that current requirements are in place to evaluate the drug’s performance prior to FDA submission.

  • Nutritional, OTC, ANDA
  • OTC Switch Strategy
  • Technology Assessment
  • Due Diligence
  • FDA Submission Development
  • Expert Witness