Regulatory Affairs
Services

 

typical regulatory projects

Our team has hundreds of years of combined experience in the industry and at the FDA. We apply the knowledge we’ve gained with rigor to regulatory projects such as: 

  • Regulatory Strategy Development

  • Submission Preparation

  • Chemistry, Manufacturing and Controls

  • Regulatory Agency Interactions

Our Services Are Unique By Industry

Our team helps you navigate the maze of global regulations and standards that products and quality systems must meet in order to satisfy regulatory requirements. The nuances between products, classifications, testing requirements and compliance standards require customized regulatory project planning for each industry.

Medical Device

There’s seemingly no end to the compliance requirements the medical device industry must meet. With both pre-market to post-market support, our experts can help with everything from regulatory strategies and due diligence to audits and compliance handling.

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Pharmaceutical

Compliance standards for pharmaceutical companies are complex — for good reason. Our regulatory experts can successfully navigate all pre-market and post-market needs, from regulatory strategies and due diligence to audits and compliance handling.

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