Regulatory Affairs

compliance - a STATE of accordance; a GOAL

In the simplest of terms, the interface between your organization and regulatory authorities is intended to protect the public health by ensuring that the drug and device products are safe, effective and secure. But it is so much more complex. As globally competitive companies strive to accelerate innovation and move life-saving therapies quickly to market and the patients they serve, navigating the ever-changing regulatory requirements is one of the top challenges facing small and large organizations.

The Catalyst Group addresses the needs of clients through the application of expert knowledge in Regulatory Affairs across the lifecycle of products in both Drug and Device categories. From concept to commercialization, our experts bring decades of industry experience to the table.

  • CMC & Manufacturing
  • Post-Marketing maintenance
  • Regulatory Strategy
  • Advertising/Promotion/Labeling
  • Filing
  • Clinical & Non-Clinical
  • Regulatory Operations & Publishing

"Our TCG consultant was a huge asset to our laboratory quality and operations improvement program. Not only was she able to see the big picture and offer practical solutions, but her ability to serve as a coach and mentor really motivated us toward our goal."

Laboratory Quality & Compliance Expert, Oncology Pharmaceutical Research

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Failure to follow established company procedures was one of the top three reasons for FDA 483 observations in 2013. Discover 3 ways you can minimize human error right now.