UK, EU, US, LATAM & APAC PHARMACEUTICAL QUALITY & COMPLIANCE CONSULTANCY
Measurable impact.
At every engagement
TDP provides pharmaceutical quality and compliance solutions for global supply chains. From QP batch certification and GxP auditing to regulatory affairs and remediation, we provide the right expertise at the right time.
Delivering value for patients who can’t wait.
DELIVERED SINCE 2024
15+
COUNTRIES SUPPORTED
30+
PROJECTS DELIVERED
03+
LICENCES SECURED, BUILT & OPERATED
WHAT WE DO
Expert GMP, GDP & regulatory consultancy across the full compliance lifecycle
From on-demand pharmaceutical advice to QP services, auditing, training and enterprise builds. TDP provides the right expertise at the right time, wherever you are in the world.
-
ESSENTIALS
Fast, flexible support for regulated teams. Includes Just Ask; on-demand expert advice within 24-48 hours. And Global GxP Auditing as a Service for risk-based audit delivery worldwide.
-
CONSULTING
Specialist delivery across RP and QP services, CMC, MS&T, Regulatory Affairs, GMP batch review and Compliance Remediation. Standalone projects or long-term retained support.
-
TRAINING
Role-based, GMP, Regulatory and Quality systems training built around your products, processes and inspection risks. Bespoke to your organisation.
-
ENTERPRISE
Build, scale or transform. End-to-end licensed entity builds, investment-ready commercial packages and fully outsourced quality, regulatory and CMC functions.
-
DUE DILIGENCE
Rapid, structured due diligence across commercial viability, CMC, regulatory strategy, quality systems and market access. Built for speed and delivery.
PROJECT HIGHLIGHTS
Work that moves the needle
A track record of delivering under pressure, across borders, for patients who can't wait.
GENE THERAPY | QP SERVICES
Uninterrupted gene therapy supply to UK and EU clinical trials
Specialist QP/QA support for complex ATMP products supplying live clinical trials for an orphaned disease. TDP navigated US-to-UK/EU regulatory complexity and maintained a continuous supply chain across a 20-month engagement.
20
Months of uninterrupted QP support
UK&EU
Dual jurisdiction compliance
ATMP
Advanced therapy specialist
00000
Disruptions to clinical supply
COMPLEX BATCH REVIEW
70GB+
Data reviewed across 7 AAV batch records
Over two months, TDP reviewed more than 100,000 pages of records, resolving major and critical deviations to enable essential medicines to reach patients.
NHS BLOOD PLASMA DERIVED PRODUCT
15
CALENDAR DAYS
From instruction to final report
TDP mobilised a specialist team within 7 days in China, completed a four-day audit, managed supplier responses and delivered QP sign-off for a critical NHS supply tender.
INTERIM LEADERSHIP | BLUE CHIP PHARMA
Global Director of Audit Interim placement at a pharmaceutical multinational
TDP's consultant reviewed global audit processes, conducted training audits integrating EU and US GMP per ISO 19011, and revised the company's global audit plan. The engagement bridged critical EU compliance knowledge gaps within the client's US-based audit team.
Revised global audit plan and schedule
DELIVERED
EU GMP competency uplift for US team
DELIVERED
Risk-based vendor assurance programme
ALIGNED
REGULATORY COMPLIANCE
MHRA inspection passed with zero outstanding findings
Following a nine-month WDA remediation engagement, TDP rewrote and reissued the client's full SOP portfolio and addressed all compliance gaps. The MHRA inspection concluded with no outstanding issues.
RARE DISEASE | AAV | QP SERVICES
300+ hours to get a life-changing AAV therapy to patients on time
Facing a critical staffing shortfall, TDP's QP support team maintained a batch-per-month release cadence over three months, ensuring patients gained timely access to a potentially life-changing treatment within budget.
CLIENT TESTIMONIALS
Trusted by quality and regulatory leaders worldwide
"TDP is a privilege to work with. Thomas and the team work efficiently with extreme diligence and care, providing prompt batch review records that allow easy and expedient batch release of ATMP IMPs."
HEAD OF QUALITY
Pharmaceutical Company
"Lucia is a privilege to work with — an exceptionally diligent and pragmatic QP. She enabled us to obtain our MIA from scratch. The inspector said it was the first time in 10 years she had given no observations and not even a comment."
MANAGING DIRECTOR
SME Pharmaceutical Company
"TDP has helped me build out my QMS to enable UK WDA registration with only comments from the Inspectorate. They always met the agreed timelines, allowing for easy project management."
HEAD OF QUALITY
EU Pharmaceutical Company
"Thomas has a broad knowledge of all GXPs and quality regulations on a global level. He identified multiple major and critical findings on high-profile contractor audits. A skilled auditor and an outstanding contract partner."
HEAD OF AUDIT
Multinational Pharmaceutical Company
"Having access to TDP means I have had access to precise, detailed and well-researched advice. It has enabled us to solve importation, supply chain and quality issues. The speed, variety and professionalism of service is impressive for such a young company."
CEO
UK Pharmaceutical Company
"Nick is known for his ability to identify poor practice and unlike many auditors he doesn't just report it. He explains the issues and consequences to both the client and the individual. He is always willing to go the extra mile."
SENIOR DIRECTOR
Pharmaceutical Company
LATEST INSIGHTS
From the TDP knowledge base
Learn what a Qualified Person (QP) does, when one is required, and how QP certification works under EU & UK GMP. Practical guidance from TDP.