Audit-tested expertise
Our principals have led Quality through FDA Pre-Approval Inspections, EMA inspections, and partner audits. We've sat on both sides of the table.
Right-sized for early-stage
Pre-IND through Phase 3. Fractional Head of Quality, single audit, or anything between. Senior principal with vetted consultant network.
Massachusetts-based, FDA-fluent
Cambridge biotech corridor and Northeast region. On-site or remote. Versed in FDA, ICH, and EU GMP requirements.
Built by quality leaders, for biotechs racing to the clinic.
Most early-stage biotechs face the same dilemma: hire a full Head of Quality at $300K+ before you need one, or wait — and risk a 483, clinical hold, or failed Pre-Approval Inspection that costs ten times more to fix.
CPC was founded to give you a third option. With over 80 years of collective senior pharma and biotech Quality, Validation, and Audit experience, we provide the leadership you need to maintain momentum without the overhead of a full internal QA organization.
REGULATORY FLUENCY
FDA · EMA · ICH Q9/Q10/Q12 · 21 CFR 210/211 · 21 CFR Part 11 · EU GMP Annex 1 · GAMP 5 · ISO 13485 · ISPE