Regulatory Affairs

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The Regulatory Affairs team at CDS has the real world experience to guide you in the best strategic direction, saving valuable time and resources.

Learn how a Regulatory Strategy tailored to your organization can drive your success.

At the outset of your development plan, sound advice from a Regulatory Consultant is critical.

From strategic planning to submission, CDS offers complete Regulatory Consulting services.

Our Regulatory Experts can provide:

  • Development of a complete Regulatory Strategy

    • Serves as a guide to achieve product development objectives your overall business goals.

  • New Drug Applications (NDA’s), Abbreviated Drug Applications (ANDA’s), Supplemental New Drug Applications (SNDA’s)

  • Clinical Trial Applications (CTA’s)

  • Label and Advertising Review

  • Drug Master Files (DMF’s)

  • Other Regulatory Compliance Issues

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Interacting with Regulatory Bodies like the FDA, HC and EMA can seem overwhelming and complicated -

Let the CDS team make the process smooth and effective for you.