A senior Quality and Compliance practice. Built for biotech.
CPC was founded on a simple premise: the most valuable consultant is one who's already done your job.
EXPERIENCE
Decades of Senior Principal Practice
Our principals bring 20–30 years of senior leadership experience in Quality, Validation, and Audit, having directed operations at top-10 global pharma and innovative clinical-stage biotechs.
Global Agency & Regulatory Proficiency
Proven mastery in leading FDA, EMA, MHRA, and PMDA inspections. We are deeply versed in the requirements of ICH Q9/Q10/Q12 and the latest EU GMP Annex 1 (2023) updates.
Complex Submission Management
Strategic leadership across IND, NDA, and BLA submissions. Our experience spans traditional small molecules, biologics, and advanced modalities including cell and gene therapies.
End-to-End QMS Scaling
We design and construct phase-appropriate Quality Management Systems (QMS) that scale seamlessly with your pipeline, from pre-clinical stages through full commercial operations.
Active senior practitioners. Full credentials and specific project successes are shared under NDA during initial scoping and consultation.
The Fractional Model: Seniority Integrated.
Most CPC engagements begin with Fractional QA Leadership—a senior principal serving as your accountable Head of Quality on a 1–3 day per week basis. This model scales seamlessly during high-stakes periods, such as inspection sprints or QMS builds. Every engagement is led by a principal who stays directly in the work, supported by a curated network of vetted technical consultants when specialized depth is required. We provide the leadership of a full-scale QA organization without the associated overhead, ensuring your quality systems evolve ahead of your clinical milestones.
Senior, always.
Every CPC engagement is led by a principal with 20–30 years of senior experience. We stay in the work, delivering the technical authority required for early-stage biotechs without the overhead of a full Quality organization.
Practical over theoretical.
We prioritize audit-defensible execution over abstract compliance theory. Having led through FDA Pre-Approval Inspections and EMA audits, we build phase-appropriate systems that accelerate your path to the clinic.
In it for the long term.
We view ourselves as an extension of your leadership team. Our goal is to build quality foundations that scale seamlessly from pre-IND trials through commercialization and strategic due diligence.