CMC Compliance Services, LLC
↗Bridgewater, New Jersey, USA
CMC Compliance Services is a specialized consulting firm providing strategic and technical expertise in Chemistry, Manufacturing, and Controls (CMC) for the life sciences industry. The company focuses on helping pharmaceutical and biotechnology firms achieve regulatory compliance throughout the product lifecycle, from early-stage development to commercial manufacturing.
The firm provides a wide range of services including regulatory filing support (IND, NDA, BLA, MAA), Quality Management System (QMS) development, GMP/GLP auditing, and supply chain oversight. They are particularly active in assisting small-to-mid-sized biotechs that lack internal regulatory infrastructure to meet stringent FDA and EMA requirements.
CLASSIFICATION
SIZE & FINANCIALS
Employees:1-50
Revenue:$1M-$5M
Founded:2014
Ownership:private
Status:operating
PIPELINE
Stage:Commercial
Lead Drug Stage:N/A (Service Provider)
Modalities:Small molecule, mAb, Cell therapy, Gene therapy
Active Trials:0
Trial Phases:-
FDA Approvals:0
EMA Approvals:0
CORPORATE STRUCTURE
Key Partnerships:Various mid-sized biotech firms, Contract Manufacturing Organizations (CMOs)
COMPETITION
Position:Niche Player
Competitors:Lachman Consultant Services, ProPharma Group, Parexel Consulting, Compliance-Pro, NSF Health Sciences
LEADERSHIP
Key Executives:
Amit Trag - President & Principal Consultant
Scientific Founders:Amit Trag
LINKS
Website:cmccompliancesvcs.com
LinkedIn:LinkedIn Profile
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