Bridging the Gap Between Regulatory Expectations and Operational Reality
Commitment to PRODUCT REALIZATION, Quality, and Patient Safety.
Founded on decades of frontline experience, PQC, Inc. was established to prevent regulatory failures and compliance-related disruptions. We believe that robust quality systems are the foundation of pharmaceutical innovation. We recognize that there are many approaches to establishing Phase Appropriate cGMPs however and and too much, too early can come at the expense of product development and producing the next lot to support a pivotal trial.
Our mission is to provide the high-level technical oversight necessary to navigate the complexities of modern drug development, from ATMPs to global commercial launches.
Decades of Leadership in Quality & Manufacturing Excellence
Michael Skidmore, Principal Managing Partner, is a globally recognized expert in cGMP compliance and biopharmaceutical manufacturing. With a career spanning roles as an FDA Investigator, VP of QA/QC, and current PDA ATMP Advisory Board founding member, Michael provides a rare dual perspective on the regulatory landscape.
From designing eQMS for vaccines to leading remediation for major pharma players, his work is driven by a passion for technical excellence and a commitment to industry-shaping standards.
Navigating Complexity Through Proven Expertise
US & Global cGMP Compliance
Design and implementation of robust, phase-appropriate Quality Systems (GMP, GLP, GCP).
Strategic QMS Design
Rapid gap analysis, establishment of 2-5 year maturity and growth plans, and execution of remediation plans to mitigate critical compliance risks.
FDA Inspection Readiness
Expert-led cGMP audits and mock inspections to secure FDA and global regulatory approval.
ATMP & Cell/Gene Therapy Expertise
Full-cycle validation for facilities and processes, ensuring seamless technology transfers.
Clinical Hold & Consent Decree Avoidance
Specialized quality oversight for CAR-T, Gene Therapies, and complex biological products.
Validation & Tech Transfer Leadership
Domestic and international product tech transfers, PMO establishment and technical training to realize scale up or scale out for supply realization. Success in transfers to and from US, EU, APAC and LATAM markets.
A Proven Track Record with Global Industry Leaders
Integrity and technical precision have made PQC a preferred partner for the world’s most demanding life sciences organizations. Michael Skidmore’s expertise is sought after by global leaders to navigate critical regulatory crossroads and ensure operational continuity.
PQC is an Approved Service Provider for Top-10 pharmaceutical corporations and emerging biotech innovators in the US, EU, and China. We provide the high-level oversight required for complex supply chains, large-scale cGMP auditing, and international compliance strategies.
Trusted by leaders in Cell and Gene Therapy, we specialize in building phase-appropriate quality systems that support rapid innovation without compromising regulatory integrity.
As a former FDA Microbiologist/ Investigator and Sr Technical Auditor for the NIH Clinical Center's ATMP suppliers, Mr. Skidmore brings a broad background in early and late phase compliance expertise.
As a Verified Veteran-Owned Small Business (SDVOSB) and GSA/SAM listed entity, PQC is uniquely positioned to support government contracts and public health initiatives, providing the same rigor expected by federal regulatory agencies.