Regulatory Affairs

Regulatory affairs activities 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). We also collaborate with European regulatory affairs experts. 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.