FDA – CVM

The Pharmobedient Regulatory and Technical team brings extensive experience in working with the US Food and Drug Administration (FDA)’s Center for Veterinary Medicine (CVM). Our focus is on the successful development and timely approval of new and generic animal drugs. We can help maximize support the product development and filing process by offering and reduce the time to market with a broad range of regulatory services that include list below.

Drug Development

N

Direct and Control the Process QbR product development planning

N

Optimize the timeline & manage the budget

N

Avoid Pitfalls from the beginning

N

CMO evaluation

CMC & Regulatory Strategy

N

Design a successful strategy from the start

N

Formal & Informal CMC Correspondence with CVM

N

CMC Protocol & Report Review

N

CMC Technical Section Writing

N

Deficiency Letter Response

N

Pre and Post-approval CMC Submissions

N

Regulatory strategy for technical transfers

Clinical & Safety

N

Assist in study design and protocol development leading to concurrence with FDA/CVM

N

Bioequivalence/Clinical study management

N

Protocol design & submission

N

White paper review

Get in Touch

6 + 4 =

COMPANY

Strategy for complex issues in drug development and life-cycle management.

CONTACT

642 NE 3rd Avenue
Fort Lauderdale FL 33304

TEL. #

(954) 348-9455