Regulatory Affairs Practice

Our Regulatory Affairs Practice has dedicated internal resources to meet the mission critical and often timely challenges our client’s 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 key to Regulatory success.

The Regulatory Affairs Practice provides consulting services in:

• Global Submissions (IND, IB,CSR, NDA, BLA, MAA, etc)

• Global Labeling (All areas of clinical and post marketed labeling)

• Regulatory Operations

• Regulatory/CMC

• Medical/Regulatory Writing