Regulatory Affairs
Regulatory affairs include working with the Center for Veterinary Medicine at the Food and Drug Administration (FDA/CVM), Environmental Protection Agency (EPA) and the United States Department of Agriculture (USDA). Activities include:
- Developing regulatory strategies, plans, and timing
- Conducting or assisting with pre-development meetings with regulators
- Liaising with regulators as a project moves forward
- Preparing and submitting background for meetings
- 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 and helping prepare CMC submissions
- Serving as US agent for ex-US companies bringing their products to the US for regulatory approval
To request more information on AlcheraBio’s Regulatory Affairs services, please click here.