Animal Health Consulting
Regulatory Compliance Solutions (RCS) has worked with small, start-up animal health companies and large, multinational corporations. Our experts have decades of experience in the animal health space. Our experience includes successfully gaining approvals for NexGard® Chewables for Dogs, Heartgard® Plus Chewables for Cats/ Dogs, and other well-known brands. We assist companies who seek regulatory assistance with the following:
FDA Center for Veterinary Medicine (FDA CVM)
- Regulatory strategy and project timelines
- Electronic filing using CVM eSubmitter and NexGen
- Pre-INAD activities during proof-of-concept phase
- FDA CVM pre-submission conferences (PSC)
- Opening Investigational New Animal Drug (INAD) files
- Protocol and study report reviews
- Creation of labeling and FOI Summaries
- New Animal Drug Approvals (NADA) for companion or production animals
- Generic New Animal Drug Approvals (ANADA) for companion or production animals
- Submission of suitability petitions
- Conditional Approvals including those for Minor Use, Minor Species (MUMS)
- Veterinary Device Review
- Unapproved Animal Drugs
- Indexed drugs
- ADUFA Fee Waivers
- Pet Food (FDA, AAFCO, and state requirements)
- Pet supplements and probiotics
- Veterinary Innovation Program (VIP)
NexGard® and Heartgard® are registered trademarks of Boehringer-Ingelheim Animal Health.
CVM Post-Approval Activities
- CMC submissions including CBE-0, CBE-30, and Prior- Approval Supplements (PAS)
- Updates to or submission of new Veterinary Master Files (VMF)
- Updates to approved labeling not otherwise provided in a DER/annual report
- Adding a new drug distributor
- Supplemental NADAs (sNADA) involving safety and/or effectiveness changes (e.g., new claims)
- Annual reporting for conditional approvals
Life Cycle Management
- Establish life cycle strategy, milestones and timelines
- Submission of Drug Experience Reports (DER) and Minor Changes and Stability Reports (MCSR)
- Submission of advertisements and promotional materials
- Pharmacovigilance reporting, including adverse drug experiences, product or manufacturing defects
- Antimicrobial reporting
