CCG Biotech Quality & Compliance Consulting
Specialized QA, Compliance & Inspection-Readiness Support for Biotech Organizations.We provide targeted, confidential, senior-level quality leadership for early-phase and commercial-stage biotech, biologics, radiopharmaceutical, and combination-product companies. From QMS development and validation strategy to audit readiness, GMP compliance, CDMO/CRO oversight, and vendor qualification, CCG ensures your quality systems are aligned, efficient, and inspection-ready.We find the gaps long before the FDA does.
What We Do
What We DoCCG provides targeted QA, compliance, and regulatory-aligned support for biotech teams that need senior-level expertise — without the cost or commitment of full-time staffing. We stabilize, rebuild, or elevate quality systems so your organization can move quickly — and stay inspection-ready.Core Areas of Expertise– GMP & phase-appropriate QMS development
– CDMO/CRO oversight, qualification & ongoing GMP monitoring
– Data integrity investigations & documentation remediation
– CAPA, deviation, OOS, and change-control leadership
– Validation strategy (process, methods, equipment)
– Regulatory support for IND/BLA quality sections
– Internal audits, mock FDA inspections & inspection readiness
– 483 response strategy, warning letter remediation & consent decree support
– Pre-submission QA review for IND/IDE/BLA filings
– Quality leadership for early-phase buildouts or commercialization prepHow We WorkWhether you need 10 hours a month of strategic guidance or 30+ hours a week of hands-on support, CCG integrates seamlessly with your team and resolves issues before they become findings.We deliver direct, senior-level QA guidance without the scope-inflation, unnecessary layers, or consultant stacking that slows teams down at larger firms.We identify gaps before the FDA does — discreetly, efficiently, and with the precision and expertise gained from decades of real-world QA leadership and proven outcomes.
The Team
The TeamCCG is a small, senior-level consulting group with deep expertise in GMP quality, compliance, and inspection readiness across biologics, radiopharmaceutical, and combination-product programs.Our consultants bring leadership experience from:- GE Healthcare (PET/Radiopharmaceutical Division)- Sanofi (Biologics Operations)- Merck- PfizerWe operate discreetly, efficiently, and with the depth of a full QA organization — without the overhead.
Contact Us
For inquiries or project quotes, please contact:Phone: 347-255-3132
Email:[email protected]
Please include a brief description of your project needs.LinkedIn:
Confidential Compliance Consulting