Regulatory Affairs

Our regulatory affairs practice has dedicated resources to meet the mission critical and often timely challenges our clients face.

Orbis Clinical has the global regulatory expertise to meet your analytical, strategic and operational needs. We align the right capabilities with your projects to help you protect your drug development investment.  Ultimately, we know that accurate, timely submissions are imperative to regulatory success.

Services Include:

  • Regulatory Affairs Strategy
  • Global Submissions planning, writing and management (IND,IB,CSR,NDA,BLA etc.)
  • Regulatory Operations

               - Strategy

               - eCTD/CTD Publishing

               - Document Management

               - Archiving

  • Global Labeling (All areas of clinical and post market)
  • Chemistry Manufacturing and Control (CMC)

                - Strategy

                - Technical Operations

                - Submission Writing

  • Medical/Regulatory Writing
  • Advertising and Promotions

To learn more about our services, contact us today!

Toll Free: 1-866-879-1963

Phone: 781-569-0607

Fax: 866-915-6480

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