TDP supports organisations with practical GMP, GDP and regulatory delivery.
From on-demand expert advice to auditing, RP/QP services, remediation, outsourced functions, training and due diligence.
Pharmaceutical Quality, Regulatory &
Compliance Services
Why Companies Trust TDP
Regulated delivery, not just advice
We work inside GMP/GDP realities to deliver outcomes that stand up to scrutiny.
Senior operators across the lifecycle
Experienced specialists across quality, regulatory, auditing, CMC/MS&T and market access.
Practical outputs you can execute
Clear actions, defensible decisions, and measurable progress, without overcomplication.
Explore our service areas below.
Get a clear breakdown of the service, the approach, and the expertise behind it.
Essentials
Fast, flexible support for regulated teams; advice, and global audit capability.
Just Ask
(On-Demand Expert Support)
On-demand quality, regulatory and compliance
advice for time-critical GMP and audit questions.
Global GxP Auditing as a
Service
Risk-based GMP, GDP and GxP audits for internal teams, suppliers and vendors. Delivered globally with practical outputs.
Consulting
Specialist delivery across RP/QP, CMC, MS&T, Regulatory Affairs, batch review and remediation.
RP & QP Services (UK & EU)
Responsible Person and Qualified Person services to support batch certification,
oversight and compliant supply continuity.
CMC, MS&T & Regulatory
Affairs Consulting
Specialist CMC, MS&T and Regulatory Affairs support aligned to product lifecycle
stage and global approval strategy.
GMP Batch Review as a
Service
Independent GMP batch
record review to reduce
release bottlenecks and
maintain inspection-ready
batch disposition.
Compliance & Remediation
Pragmatic remediation
programmes for inspection
findings, regulatory
observations and systemic
quality gaps.
Enterprise
Build, scale or transform — compliant
operating entities, investment-ready assets, and outsourced functions.
Built for You
(Entity & Licence
Build)
End-to-end build of
licensed, inspection-ready
entities and operating
frameworks for market
entry and execution.
Built to Buy (Commercial
Package & QMS Build)
Investment-ready
commercial packages and
scalable QMS designed to
reduce diligence risk and
increase asset value.
Outsourced Functions
(Quality, Regulatory, CMC, MS&T)
Fully outsourced
departmental capability
delivered as an extension
of your organisation,
without internal build-out.
Training
Role-based GMP, regulatory and quality
systems training built around your products,
processes and risks.
Bespoke GMP Training
Practical, role-specific GMP training designed to improve inspection readiness, strengthen compliance understanding and support confident decision-making in regulated environments.
Quality Systems Training
Tailored QMS training designed to help teams understand, operate and defend effective quality systems in line with regulatory expectations.
Regulatory Training
Bespoke regulatory affairs training designed to strengthen understanding of regulatory requirements, submission expectations and lifecycle responsibilities across target markets.
Role based and Inspection readiness Training
Focused training designed to prepare teams for regulatory inspections by building role-specific confidence, accountability and the ability to respond effectively under scrutiny.
Due Diligence
Rapid, structured due diligence across
commercial viability, CMC, regulatory, quality
and market entry.
Commercial Viability Analysis
Rapid viability assessment
integrating technical,
regulatory, manufacturing
and market considerations
for deal decisions.
CMC & Regulatory Due
Diligence
Due diligence to assess
development readiness,
approval risk and lifecycle
strategy across global
regulatory pathways.
Quality & Technical Due
Diligence
Assessment of QMS
maturity, compliance
history, inspection
outcomes and technical
operations to surface hidden risk.
Market Access & Market
Entry Due Diligence
Evaluate pricing,
reimbursement, entry
readiness and regulatory
alignment to validate go-to-
market assumptions.
“TDP has been an invaluable partner in helping us navigate complex quality, regulatory and compliance challenges. Their advice is always practical, risk-based and commercially grounded, giving our teams the clarity and confidence to make robust decisions in a highly regulated environment.”
Managing Director, European Pharmaceutical Manufacturer