What We Do
Six services. One operating principle.
Every engagement is led by a senior principal with 20–30 years of operational experience. Most clients start with one service and expand as their pipeline matures.
Core Offering
Fractional QA Leadership
Early-stage biotechs often lack the scale for a full-time Quality head but face high-stakes risks during IND submissions and clinical transitions. CPC provides the senior leadership you need without the overhead of a permanent role.
- Acting Head of Quality on a recurring 1–3 day basis
- Strategic oversight of CMO/CDMO partners
- Quality representation during board and diligence meetings
- Leadership during pre-inspection sprints
Quality Systems Design & Remediation
A QMS must evolve as you move toward the clinic. Rigid paper-based systems or ad-hoc digital folders create compliance debt. We design phase-appropriate systems that scale with your pipeline and survive regulatory scrutiny.
- Phase-appropriate QMS architecture (Pre-IND to Phase 3)
- SOP authoring, review, and simplification
- Remediation strategies following a 483 or audit failure
- Change control and CAPA system optimization
Product Quality & Operations
Ensuring audit-defensible GMP execution requires technical mastery and constant vigilance over CDMO partners. We manage the operational quality details so your CMC team can focus on development.
- GMP batch record review and disposition
- Stability program oversight and PQR preparation
- Manufacturing site assessments and person-in-plant support
- Master batch record and specification technical review
Validation, CSV & Data Integrity
Data integrity is a primary focus for FDA and EMA inspectors. Cloud-native biotechs must prove ALCOA+ standards across every digital asset. We bring GAMP 5 and 21 CFR Part 11 expertise to your validation projects.
- ALCOA+ data integrity gap assessments and remediation
- 21 CFR Part 11 and Annex 11 compliance mapping
- Validation of cloud-native lab and quality systems
- Equipment and process validation strategy and execution
Digital Quality (eQMS / eDMS)
Moving from SharePoint to a purpose-built system like Veeva, MasterControl, or ZenQMS is a high-risk transition. We guide you through vendor selection and implementation to ensure the system serves your pipeline, not the other way around.
- Vendor selection based on phase and scale requirements
- Implementation strategy and configuration oversight
- User requirement specifications (URS) and validation support
- Post-implementation administrative governance
Inspection Readiness & Due Diligence
Uncovered compliance gaps can derail clinical holds or acquisitions. We provide mock PAIs and technical gap assessments to find what an inspector or acquirer would find—while you still have time to fix it.
- Mock Pre-Approval Inspections (PAIs) and site audits
- Technical gap assessments (Pre-IND, CMC, and GMP)
- Target-side or buyer-side due diligence for acquisitions
- Back-room and front-room training for technical staff
We also deliver training on CSV, CSA, data integrity, and GMP fundamentals.