Regulatory Affairs

The regulatory landscape is constantly changing and new technologies are being introduced. Whether you are launching a new product or re-purposing an existing drug for a new therapeutic use, we can help you efficiently navigate the regulatory processes. We have a great track record with the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA). We also collaborate with European regulatory affairs experts.

Our services include:

  • Developing regulatory strategies

  • Conducting or assisting with pre-development meetings with regulators

  • Drafting protocols based on regulatory requirements

  • Negotiating and resolving regulatory issues

  • Preparing presentations and attending meetings with regulators

  • Reviewing chemistry, manufacturing, and controls (CMC) plans

  • Serving as a US agent for non-US companies bringing products to the US for regulatory approval

Other Services

Clinical Services
Data Management
Quality Assurance