Drugs and Bioscience
Current Good Manufacturing Practices (CGMP)
Ensure Compliance with FDA cGMP Standards for Drug Products
Trusted Support for Manufacturing Drug Products under 21 CFR Part 210 & 211
At JJCC Group, we help pharmaceutical manufacturers meet the minimum Current Good Manufacturing Practice (CGMP) requirements as set forth in 21 CFR Part 210 and 211—the FDA’s regulatory framework for ensuring the identity, strength, quality, and purity of drug products administered to humans and animals.
Whether you are developing prescription drugs, over-the-counter (OTC) medications, or veterinary pharmaceutical products, our expertise ensures your manufacturing processes are fully compliant, audit-ready, and quality assured.
Our Services Include:
✅ GMP Facility Design & Setup
✅ SOP Development & Documentation
✅ Process Validation & Quality Assurance
✅ Batch Record Creation & Review
✅ GMP Audits & Mock FDA Inspections
✅ Personnel Training on cGMP Compliance
✅ Consulting for Compliance with Parts 600–680 for Biologic Products
Our Specialized Services:
✅ Contract Manufacturing
Efficient, FDA-compliant production of oral solids, injectables, topicals, and more. Whether clinical or commercial scale—we bring your formulation to life with precision and quality.
✅ CDMO Services
From early-stage development to full-scale manufacturing, our Contract Development and Manufacturing Organization (CDMO) solutions include formulation, analytical services, validation, and packaging—so you can focus on innovation while we handle the rest.
✅ Biologics Expertise (21 CFR 600–680)
Navigate the complex regulatory landscape for biologic products, including vaccines, blood components, and gene therapies. We ensure your development and manufacturing processes align with the latest FDA guidance and CGMP requirements.
✅ GMP Training Programs
Equip your team with the knowledge to stay compliant. We offer customized, hands-on CGMP training courses for pharmaceutical, biologics, and nicotine product manufacturers—covering Part 210/211 and beyond.
Why Choose Us?
🔹 Deep knowledge of FDA requirements
🔹 Specialized focus on non-PET drug products
🔹 Support for both human and veterinary applications
🔹 Scalable solutions for startups, CDMOs, and legacy manufacturers
🔹 Real-time updates on evolving regulatory expectations