Elevating Quality,
Ensuring Compliance

PQP Group enables pharma, biotech & CGT sponsors and manufacturers with speciality pharma services, including audits, clinical material importation & release to drive growth & compliance.

Discover the
Values That Shape
Everything We Do

We are consulting and industry experts that help pharmaceutical, biotech and cell and gene therapy companies establish or remediate quality systems, mitigate risks and achieve sustainable compliance.

Do you need support or consultation?

Comprehensive Quality & Regulatory Solutions

We provide specialized quality, compliance, and risk-management solutions tailored for pharmaceutical, biotech, and cell & gene therapy organizations. Our experts help you build reliable systems, achieve regulatory readiness, and maintain long-term operational excellence.

Insights, Announcements & Events

Strengthening Quality Systems in a Rapidly Evolving Life Sciences Landscape

Why Risk Mitigation is Becoming a Top Priority in Pharma and Biotech

The Growing Importance
of Compliance Readiness in Cell & Gene Therapy

Quality System
Remediation: A Rising Need After Regulatory Findings

Strengthening Quality Systems in a Rapidly Evolving Life Sciences Landscape

Strengthening Quality Systems in a Rapidly Evolving Life Sciences Landscape

Blogs / Articles

Outsourcing Advanced Biologics and Cell & Gene Therapies to China: A Growing Opportunity with Deep Technical Risk

Enabling Pharma Companies to Launch AI That Holds Up to Regulatory Scrutiny

Selection, Awarding, and Technology Transfer into a CDMO: A Comprehensive Guide for Pharmaceutical Operations

FDA, EMA, MHRA, Health Canada, TGA Inspection readiness – Avoid the Car Crash

Auditing – Why Bother?

The Hidden Cost of a Misaligned Quality Management System (QMS) in Pharma

Helpful Answers to
Common Queries

Browse through our frequently asked questions to better understand how we work, what we offer, and how we can help your teams achieve quality and compliance goals.
What sets PQP Group apart from traditional consultancies that only advise rather than execute?

Unlike advisory‑only firms, PQP operates licensed UK and EU facilities and provides hands‑on execution across quality, clinical, supply chain, technical and regulatory activities, enabling clients to progress programs with compliant, real‑world operational delivery.

Pharmaceutical innovators, emerging biotech, CGT (Cell & Gene Therapy) companies, global manufacturers seeking to expand their footprint, and investment groups evaluating technical opportunities all rely on PQP’s integrated execution and expert guidance to scale safely and effectively.

PQP provides expert guidance and operational execution for organisations unfamiliar with UK/EU regulatory pathways, importation requirements, and clinical trial expectations, helping them accelerate in new regions confidently and compliantly.

PQP rapidly mobilises experienced GxP auditors worldwide, leveraging our flexible consultancy model and established quality frameworks to schedule and perform GxP audits at short notice. This enables clients to maintain appropriate global supplier management standards, verify compliance across complex supply chains, and address urgent qualification or remediation needs without delaying programme progress.

PQP delivers rapid, confidential due‑diligence assessments across quality, clinical, regulatory, manufacturing and supply chain domains, providing investors with actionable risk insights and feasibility evaluations to guide confident decision‑making.

PQP provides senior‑level clinical project management leadership integrated with quality, regulatory and technical functions, ensuring not only study execution but full programme alignment, risk governance, and strategic cross‑functional coordination.