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Regulatory and Compliance Solutions

With rapid technological boom and swift development of healthcare products, life science environment is changing exponentially. Today it is challenging than ever to understand the entire regulatory requirement to bring a product to market shelves.

STS Compliance Solution team of professionals offers expertise to lead or support FDA filings. Our solutions will help in developing focused customized plan for submissions with pre-submission and post-submission interactions with regulatory authorities. Our regulatory experts have specialized knowledge of the many regulatory jurisdictions.

We offer strategic guidance at every stage of the product development process. STS Compliance Solution provides expert regulatory support in:

  • Regulatory assessment
  • Agency interaction – Represent client during pre-IND meetings and other interactions.
  • Global regulatory strategy development
  • Pre-application regulatory meeting support participation, preparation, including development of pre-meeting packet
  • Prepare and Submit regulatory documents including IB, IND, IDE, CTD summaries, CTD tables, CTA, NDA, BLA, MMA.
  • Pre-market submissions: 510(k), PMA, BLA, HDE
  • FDA inspection preparation
  • FDA advisory panel preparation and meeting support
  • Acting as Designated Agent for non-US manufacturers
  • Technical papers and abstracts
  • Literature searches and bibliographies
  • Writing and developing standard operating procedures (SOPs)
  • Review and critical appraisal of technical and scientific reports and
  • Annual progress reports