One Partner for Every CMC Need
Small, agile, and scalable CMC consulting for veterinary drug development — championing your asset from strategy through approval, on time, in compliance and within budget.
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A Single Source for Your CMC Needs
Animal Pharm CMC Consulting was created to give clients one source for every CMC need — U.S. regulatory strategy, authoring and submission, drug substance and drug product support, analytical, supply chain, quality assurance, and project management.
We’re small and agile, but built to scale with your program. We treat every client’s project like it’s our own — helping you reach approval and launch on time and within budget.
Full-Service CMC Support
Regulatory Support
Deliver and drive strategy from development through commercialization by planning and leading agency interactions, preparing and submitting VMFs and DMFs, developing and refining pre reads for PSC meetings, and authoring, reviewing, and harmonizing CMC Technical Sections.
Manufacturing Support
Provide stage appropriate, manufacturing leadership by identifying and integrating CDMOs and driving DS/DP process development. We establish control strategies that ensure robust, compliant, and scalable manufacturing throughout the product lifecycle.
Analytical Support
Deliver analytical leadership during development and validation of analytical methods. Supporting, troubleshooting, and optimizing assays across modalities—from small molecules to large biologics.
Project Management
We assign a dedicated Project Manager who serves as your single point of contact, directing and coordinating SME teams that expand, contract, and realign as your program evolves. Your PM leads cross functional execution, drives communication across stakeholders and CDMOs, maintains timelines and scope, and ensures the right expertise is deployed at the right moment.
Supply Chain
Build and maintain resilient, compliant, global supply chains by driving demand planning; overseeing CMO/CPO performance; coordinating global logistics; and identifying, mitigating, and preventing risks that threaten continuity or compliance.
Gap Analysis / Due Diligence
Provide phase appropriate evaluation of asset approvability by identifying and recommending mitigations for technical and regulatory gaps. Our team reviews, verifies, and validates data packages, examines development history, evaluates compliance risks, and recommends targeted actions to strengthen readiness for next phase progression.
Experience That Hits the Ground Running
Our three principals bring more than 80 years of combined expertise in pharmaceutical manufacturing and engineering across both human and veterinary medicine, supported by over 50 years of consulting experience. Each SME contributes 25+ years of hands on, technical depth spanning analytical laboratories, production facilities, regulatory authoring, and direct collaboration with the FDA’s Center for Veterinary Medicine—ensuring every project benefits from seasoned, immediately effective leadership.
Get in Touch
Let’s Talk About Your Program
We’ll show you how Animal Pharm can help solve your CMC needs.