From day one to where we are now
A complete record of every project, engagement and milestone, from our first batch release in January 2024 to today.
JANUARY 2024
Batch Review Contract: AAV Rare Disease Product
A critical staffing shortfall threatened on-time QP batch certification of commercial AAV products for a rare disease indication. TDP's QP support team dedicated 300+ hours over three months, maintaining a batch-per-month release cadence across all product batches, ensuring patients gained timely access to a potentially life-changing treatment on time and within budget.
FEBRUARY 2024
Supplier Quality Technical Agreements: NHS Trust
Following sign-off of critical works, comprehensive QTAs were required for key suppliers across the NHS Trust's supply chain. TDP conducted a meticulous review of each QTA, assessing GMP compliance, risk controls, scope coverage, and how they interlocked with relevant SLAs. This gave the client confidence that supplier relationships were underpinned by robust quality frameworks.
FEBRUARY 2024
MIA & WDA Registration: Malta
A client needed to establish a Maltese operation for QP certification and EU product importation. TDP undertook a comprehensive EU Malta GMP review and gap assessment of the client's UK SOP portfolio against Maltese law, then reworked the portfolio to ensure full compliance with local requirements.
MARCH 2024
Strategic Supply Crisis Management: Post M&A
Following a major acquisition, available stock was insufficient to meet market demand across multiple products, risking significant government contract penalties. TDP assessed stock levels, manufacturing windows, and regulatory requirements, managing regulatory authority discussions, supply chain quality negotiations, and delivering board-level reporting. The plan was approved and executed.
MARCH - JUNE 2024
Integrated Pharmaceutical Eco-Lane Project for GDP-UCI
An ambitious co-shipping project requiring assessment of pharmaceutical transport strategies across road, rail, inland waterways, ship, and air. TDP evaluated logistical complexities, risk controls, route qualification planning, co-shipping controls, and real-time tracking solutions. Despite diligent efforts from all parties, the project was ultimately discontinued due to stakeholder cost and priority conflicts.
APRIL 2024
ISO 17025 Audit and Gap Assessment: Laboratory Start-Up
A small start-up developing testing protocols needed independent assessment to achieve ISO 17025 laboratory accreditation. In a focused 7-day engagement, TDP conducted an on-site audit and gap assessment covering QMS structure, method management, characterisation standards, and reagent management practices. The client implemented the findings and recommendations.
JUNE 2024 - MAY 2025
QP Batch Certification: Gene Therapy, Orphaned Disease
Specialist QP/QA support was required for complex gene therapy products for an orphaned disease indication, ensuring uninterrupted supply to live UK and EU clinical trials. TDP navigated the regulatory differences between the US supplier and UK/EU requirements, facilitating seamless communication and alignment across sponsor, client QPs, and the US supplier throughout the engagement.
AUGUST 2024 - SEPTEMBER 2025
IMP Manufacturing & Import Authorisation (MIA) Application
A client required comprehensive support developing and implementing a QMS tailored for a successful IMP MIA application. TDP performed a detailed GMP site inspection, SOP catalogue gap assessment, collaborative gap closure, SOP inception and train-out, and expert review of commissioning, testing, and validation protocols across the full engagement.
SEPTEMBER 2024
QMS Remediation Following Regulatory Findings: Combination Products
A client with combination medical device and pharmaceutical products needed help addressing regulatory agency findings and implementing a credible CAPA plan. TDP developed an updated communication strategy, CAPA schedule, and QMS structural recommendations, updating SOPs and establishing real-time data acquisition, trending, and reporting. The regulator specifically commended the clarity of communications and quality of documentation.
SEPTEMBER 2024
Urgent Due Diligence Audit: NHS Blood Product Supply Tender
An urgent blood-derived product audit was required for a critical NHS supply tender on an extremely tight timeline. TDP mobilised a specialist two-person audit team within 7 days of contact, completed a four-day audit, managed the supplier findings response, and secured QP Declaration sign-off. The full audit, response, and final report were delivered within 15 calendar days.
SEPTEMBER 2024
Returning Client: Complex AAV Batch Review Backlog
Higher-than-expected demand combined with production delays and staff shortages created a critical backlog of complex analytical and processing batch records. Over two intensive months, TDP completed 7 comprehensive AAV batch reviews, examining 70GB+ of data and more than 100,000 pages of records. Major and critical deviations were resolved throughout, enabling essential medicines to reach patients.
OCTOBER 2024
New Client: Generic Medicines Batch Review Surge
A sudden surge in demand for generic medicine lines created an immediate quality resource bottleneck. TDP rapidly deployed experienced QA personnel directly into the client's QMS, integrating seamlessly to address the peak workload. TDP completed 25 batch reviews for routine generic tablet formulations within four weeks, preventing market supply shortages.
OCTOBER 2024
EU and US GMP Audit: Biofermentation Facility, Florida
A biofermentation and drug substance production facility required a comprehensive compliance assessment against both EU GMP and US FDA standards. TDP's US-based audit team conducted a detailed on-site evaluation, giving the client a clear picture of their compliance standing with both regulatory bodies and enabling targeted improvements to support their global market access strategy.
OCTOBER 2024 - MARCH 2025
Interim Global Director of Audit: Blue-Chip Pharmaceutical Client
A blue-chip pharmaceutical client needed interim leadership for their global Audit Director role, with a particular focus on bridging EU compliance knowledge gaps within the US audit team. TDP's consultant reviewed audit processes and risk methodologies, conducted approximately 10 training audits integrating EU and US GMP per ISO 19011, and revised the global audit plan and schedule, strengthening the vendor assurance risk management programme.
OCTOBER & DECEMBER 2024
Returning Client: Complex Deviation Batch Recovery
Multiple batches exhibiting complex deviations threatened product release and significant Cost of Goods loss. TDP took immediate ownership of two impacted batches, conducting phased investigations in close collaboration with the QP, sponsor, and CMO. TDP formalised documentation, updated and re-evaluated insufficiently rigorous deviations, and presented for QP certification. Both batches were recovered from likely rejection.
NOVEMBER 2024
Cell Line Management Audit: Mississauga, Canada
In preparation for an upcoming technology transfer, a comprehensive audit was required covering cell line management, cultivation, storage, bespoke assay development, and proprietary processes. TDP mobilised an audit team to Mississauga, identifying significant findings related to documentation practices and development process controls. This provided a clear improvement roadmap ahead of the transfer, which subsequently proceeded.
DECEMBER 2024
Christmas Audits in China and India: Anti-Malarial NGO
An NGO working on vital anti-malarial products faced critical government funding milestones requiring audits to be conducted up to and including Christmas Eve. TDP provided high-quality auditing services at standard cost, delivering full audit fieldwork and comprehensive reporting by end of January 2025. This enabled the NGO to meet crucial funding milestones and continue their life-saving work.
JANUARY 2025
Return Engagement: China Supply Chain Audits for Anti-Malarial NGO
An NGO working on vital anti-malarial products faced critical government funding milestones requiring audits to be conducted up to and including Christmas Eve. TDP provided high-quality auditing services at standard cost, delivering full audit fieldwork and comprehensive reporting by end of January 2025. This enabled the NGO to meet crucial funding milestones and continue their life-saving work.
JANUARY 2025
USA Medical Device Importation Training: Blue-Chip Client
A blue-chip pharmaceutical company needed collaborative training on complex UK/EU to USA import and export requirements for Class 1 and 2 medical devices and combination products. TDP conducted a needs assessment, reviewed the client's product portfolio, and designed a bespoke 3-hour interactive training session incorporating Problem-Based Learning workshops. The session received highly positive feedback on content clarity and practical application.
FEBRUARY 2025
Medicinal Cannabis Market Entry Assessment: UK
A client sought to understand the barriers, compliance requirements, and QMS suitability for entering the UK medicinal cannabis market. TDP analysed viable routes to market, legal licensing requirements across the supply chain, NHS prescribing norms, specific product requirements, and necessary QMS amendments. TDP delivered a comprehensive strategic report that enabled the client to make an informed board-level decision.
FEBRUARY - NOVEMBER 2025
WDA Remediation: UK Pharmaceutical Wholesaler/Distributor
A UK pharmaceutical wholesaler required comprehensive remediation of their Wholesale Distribution Authorisation, including a major review and reissuance of several dozen Standard Operating Procedures. TDP provided expert external consultancy, writing and reissuing the full SOP portfolio alongside targeted remediation activities to address all identified compliance gaps. The subsequent MHRA inspection resulted in a clean outcome.
FEBRUARY - MARCH 2025
Outsourced Quality Unit: WDA and MIA Operational Oversight
A client required TDP to assume full operational oversight as their outsourced quality unit across both a WDA and newly acquired MIA, while simultaneously building out the MIA infrastructure. TDP took control of day-to-day quality operations, managing all RP/RPi obligations, overseeing compliance, and directing the quality systems build-out. This enabled the client to run a fully compliant licensed operation without an in-house quality team.
FEBRUARY - JUNE 2025
UK RPI Export and Import Process Build: Client Implementation
A client required the design and full implementation of a compliant UK Responsible Person for Import (RPI) export and import process. TDP built the end-to-end framework from the ground up, developing all necessary SOPs, documentation controls, and operational procedures. The result was a fully operational, compliant, and documented import/export capability ready for routine use.
MARCH 2025
Malta MIA IMP Licence: Final Close-Out and Grant
Following the earlier engagement to support the Maltese MIA application for IMP activities, the project entered its critical close-out phase. TDP supported all final activities, ensuring the QMS, documentation, and regulatory submissions were complete and compliant. The final licence grant from the Maltese regulatory authority was secured, completing a project first initiated in 2024.
APRIL - JUNE 2025
International Audit Programme: India, Spain and China
Multiple clients required on-site GMP and supply chain audits across international sites in India, Spain, and China within a compressed timeframe. TDP mobilised audit teams across all three countries, conducting approximately seven audits in total covering GMP compliance, supplier qualification, and supply chain assurance. Consistent, high-quality outputs were delivered regardless of geography.
APRIL - MAY 2025
ePaper e-QMS Launch: SharePoint and DocuSign Integration
A client required the qualification and launch of a fully paperless electronic QMS, replacing manual document workflows with a GMP-compliant digital solution. TDP qualified and deployed a SharePoint-based e-QMS integrated with DocuSign, establishing compliant digital document workflows, version control, and approval processes. The system went live by May 2025, significantly reducing administrative burden.
MAY 2025
Making and Distributing Pharma 2025 Industry Conference
TDP attended Making & Distributing Pharma 2025, participating in sessions covering the latest developments in pharmaceutical manufacturing, GDP, quality systems, and regulatory frameworks across UK and EU markets, strengthening sector insight and industry relationships.
JUNE - SEPTEMBER 2025
Team Growth: First Employed Staff and Continued Hiring
As TDP transitioned from a contractor-only model to direct employment, the business completed its first employed hire, Matthew Burns (June 2025), followed by Ottillia Fernandes (July 2025) and the conversion of Laura Orton from contractor to employee in September 2025, bringing total employed headcount to four. This gave TDP significantly greater operational capacity and service continuity for sustained client engagements.
AUGUST 2025 - MARCH 2026
Returning Client: Emergent Batch Backlog Review Programme
A returning client faced an emergent backlog of batch reviews requiring urgent QP-level oversight arising suddenly and requiring dedicated, sustained resource over an extended period. TDP deployed experienced batch review resource from August 2025, working through the backlog systematically across an eight-month engagement, ensuring continued product release and market supply continuity throughout.
NOVEMBER 2025
Tom Bryan Joins as Director of Sales & Business Development
TDP made its first dedicated commercial hire in November 2025, bringing in focused sales and business development leadership as the firm entered a structured growth phase. With a growing client base and increasing inbound interest, the appointment marks TDP's transition toward a more formalised go-to-market approach, with pipeline development and commercial process a key focus heading into 2026.
NOVEMBER 2025 - APRIL 2026
Process-Driven Development & Full Website Redesign
With a growing team and expanding service complexity, TDP formalised internal business processes across sales, delivery, quality oversight, and team management. In parallel, a full website redesign was initiated from February 2026, with the new site launched in April 2026, presenting a polished digital presence aligned to TDP's growing reputation and commercial ambitions.
FEBRUARY 2026 - ONGOING
Gene Therapy Batch Reviews: Long-Running Returning Client
A returning client continued to require specialist QP support for complex gene therapy batch reviews, with the engagement extending well beyond its initial term due to sustained demand and the highly specialised nature of the work. TDP maintained consistent QP-level expertise across advanced therapy medicinal products, navigating complex regulatory requirements across UK and EU jurisdictions throughout.
MAY 2026
New Website Live: TDP Enters Next Phase of Growth
TDP's new website launched in May 2026, presenting a fully refreshed digital presence aligned to the firm's growing reputation across UK, EU, and global pharmaceutical markets. Combined with a functioning CRM, an employed team, documented internal workflows, and a formalised commercial process, TDP is now positioned to scale with confidence.