About us

Who We Are

Meet our team over 75 years total experience

Thomas Denton - Total Delivery Pharma

THOMAS DENTON

UK/EU/ROW GMDP, GCP Quality Expert, Auditor & Trainee QP

Specialising in

  • Strategy

  • Project management

  • Validation and Compliance

  • Risk Management

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NICK DEMINICO

US/LATAM GMDP Quality Expert and Auditor

Specialising in

  • Manufacturing Operations

  • Process and CMC/MSAT

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Naresh Renikindi -Total Delivery Pharma

NARESH RENIKINDI

UK/EU QP/RP/RPi GMDP Expert

Specialising in

  • Clinical & Commercial, Borderline & Combination products

  • Manufacturing and Distribution of range of Small & Large molecules

  • Expert GMDP auditor & remediation consultant

  • Sterile products

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HEATHER PUKSTA

US GMDP Quality Leader / PM and Auditor

Specialising in

  • Quality Systems / eQMS

  • M&A or Harmonization

  • Continuous Improvement

  • Auditing and Remediation

  • Change Agent

  • Medical Device, Pharmaceuticals, ATMPs, and C&GT

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Matthew Burns - Total Delivery Pharma

MATTHEW BURNS

RP, RPi, WQP | Pharmaceutical & Medical Device Quality Leader

Specialising in

  • GDP Compliance

  • Supply Chain Strategy

  • CAPA & Risk Management

  • Operational Planning

  • Regulatory Remediation

  • Cross-Functional Leadership

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Ottillia Fernandesn - Total Delivery Pharma

OTTILLIA FERNANDES

QA specialist 

Specialising in

  • Quality Assurance across clinical and commercial pharmaceutical manufacturing

  • GMP compliance, batch record review, batch consolidation QP release, deviation/CAPA management

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 Our approach has 6 core foundations:

  • The patient is at the centre of everything we do. The Safety, Quality and Efficacy of products and services provided is fundamental to patient care and safety. Our founder has direct experience of this going wrong. Born out of these failings we have built Safety, Quality and Efficacy of products and services into our foundations. Patient safety and product and process fitness for purpose guides our every action.

  • We live by our slogan; providing solutions that are detailed-focused and tailored to our clients’ unique needs. As such placing flexibility and adaptability at the core of our services.

  • Our ethos is rooted in providing value-based consultancy and training, developing optimized solutions to complex challenges. We act with honesty, transparency.

  • Total Delivery Pharma Services upholds the highest standards of integrity and ethics in every interaction, ensuring transparency and trust.

  • We don't just promise; we deliver. Total Delivery Pharma Services is committed to ensuring that our solutions meet and exceed your expectations.

  • We look at the opportunities for improvement and opportunities for development at every stage, bringing knowledge, technological and data process to develop solutions for our clients. We utilise behavioural insights and human factors to find gross and marginal gains. Working to towards optimal system that is as simple and safe as practically possible with data acquisition and responsive KPIs built in that demonstrate real progress and cumulative gains in productivity and compliance.

Our Partners

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Our Timeline

2023

  • June 2023 – Genesis of TDP
    Founded in response to inefficiencies in pharmaceutical consulting, with a vision to deliver precise, flexible, and patient-centred solutions across the UK, US, and EU.

  • August 2023 – UK Business Formation
    Established UK entity, built IT infrastructure, and achieved Cyber Essentials certification. Plans underway for ISO 9001 & 27001.

2024

  • January 2024 – AAV Batch Certification
    Provided over 300 hours of QP support for the urgent launch of a rare disease therapy, ensuring timely patient access.

    February 2024 – NHS Supplier QTA Review
    Audited QTAs for GMP alignment and risk management across supplier agreements.

    February 2024 – MIA Set-up in Malta
    Helped secure MIA/WDA through SOP gap analysis and regulatory adaptation.

    March 2024 – Strategic Supply Crisis Support
    Guided a client through post-M&A supply shortages and regulatory complexity, helping them avoid contract fines and ensure product availability.

  • April 2024 – ISO 17025 Audit and Gap Assessment
    Supported a start-up aiming for ISO 17025 accreditation by performing a 7-day audit, gap analysis, and implementation of changes, leading to successful certification.

    April 11, 2024 – Establishing the US Presence
    Formally registered the US entity in Delaware and integrated it into the existing operational infrastructure.

    April–June 2024 – Batch Review Contract
    Supported gene therapy product certification for Duchenne Muscular Dystrophy clinical trials, ensuring continuous product supply across UK/EU by bridging US and EU regulatory frameworks.

    March–June 2025 – Integrated Eco-lane Collaboration
    Partnered with GDP-UCI to develop logistics solutions for co-shipping across transport modes. Project was ultimately shelved due to cost and conflicting priorities.

  • August 2024 – IMP MIA Application Support
    Helped a client develop and implement a QMS to secure a Manufacturing and Import Authorisation through detailed inspections, gap analysis, and validation support.

    September 2024 – QMS Remediation
    Remediated regulatory findings for a medical device/pharmaceutical product through QMS restructuring and strategic CAPA planning, resulting in regulatory approval.

    September 2024 – Urgent Due Diligence Audit
    Executed a rapid, complex audit in just 15 days to support a critical NHS supply tender, enabling the client to qualify.

    September 2024 – Returning Client – Batch Reviews
    Performed 7 complex Analytical & Accountability batch reviews involving 70GB+ of data, resolving major deviations and achieving timely QP certification.

  • October 2024 – New Client Batch Reviews
    Reviewed and certified 25 batches in just 4 weeks, helping the client meet sudden market demand and avoid shortages.

    October 2024 – EU and US GMP Audit (Florida)
    Audited a biofermentation facility for EU and FDA compliance, providing clear insight and recommendations for global regulatory adherence.

    October 2024 – Mar 2025 – Interim Global Director of Audit
    Led global audit strategy, trained US teams on EU GMP, redesigned audit plan, and strengthened supplier quality assurance.

    October & December 2024 – Complex Batch Recovery
    Recovered two major batches from likely rejection by resolving critical deviations and achieving QP certification in April 2025.

    November 2024 – First US Client Audit (Canada)
    Audited proprietary cell line management practices in Mississauga, identifying key documentation gaps for corrective action.

    December 2024 – Christmas Audits (China & India)
    Conducted urgent anti-malarial audits over the holidays for an NGO, enabling the client to meet strict funding milestones.

2025

  • January 2025 – Return to China (NGO Audits)
    Completed in-depth supply chain audits in China, ensuring the timely delivery of anti-malarial treatments and compliance with funding terms.

    January 2025 – USA Medical Device Importation Training
    Delivered targeted training on US medical device and combination product import/export compliance for a blue-chip pharma client.

    February 2025 – Medicinal Cannabis Market Entry Review
    Investigated the UK market potential for a cannabis product, providing a strategic report on licensing, QMS alignment, and barriers to entry. Client chose not to proceed.

Where are we?

We work remotely or from your site

We work efficiency and productively with no travel time

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We work on your time zone and to your availability

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Remote by design, for your needs

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Book a free 30 minute consultation to discuss your needs.

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What Our Pharma Clients Say About TDP

  • “Thomas has a broad knowledge of all GXPs/Quality regulations on a global level. Thomas has an excellent eye for detail whilst executing audits and has overall high understanding of all topics which need to be covered during an audit. I have personally audited with Thomas which involved high profile contractor audits known for critical Findings and recalls. Thomas identified multiple major/critical Findings. Thomas is a skilled auditor, and he is also in the process of training as a QP. Amazing Contract Auditor.”

    — Head of Audit, Multinational Pharmaceutical company

  • “As the CEO of a large pharmaceutical company having access to TDP and the team means I have had access to precise and detailed advise well researched and reliable. It has enabled us to solve importation, supply chain problems and quality issues. The speed and variety and professionalism of service is impressive for such a young company, led by such a young MD. Privilege to work with. Looking forward to a long and strong partnership as a member of my senior advisory team!”

    — CEO large pharmaceutical company

  • “Thomas’s is an auditor of a type and Quality the like I have rarely encountered. The depth and detail of his work is phenomenal, not only that he took the time after the audit was said and done to give us a brief set of option appraisals to answer mine and my teams' questions in full and with pragmatism.”

    — Head of Quality, Multinational Pharmaceutical Manufacture Company

  • “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 and QP

  • “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 and QP

  • “Thomas was a colleague of mine whilst I was acting as a Qualified Person. He displayed a comprehensive knowledge of applicable legislation and industry GxP expectations. His meticulous planning was of great benefit during GMP audits and together with his flair for technology and software made him a pivotal team member.”

    — QP and Ex Inspector

  • “Lucia is a privilege to work with an exceptionally diligent and pragmatic QP, she enabled us to obtain our MIA, building it from scratch to meet our custom and quite nesh needs. Moreover, the inspector when granting us our licence said that in the last 10 years this is the first time, she has given no observation and not even a comment!”

    — Managing director SME pharma company

  • “Lucia’s passion for patient first, is evident in all she does. Her technical acumen and attention to detail makes her an asset! What is more important is that she educates and explains always making the time.”

    — Head of Quality and QP

  • “Nick is known for his ability to see and smell out poor practice, but unlike many auditors/consultants he doesn’t just report it. He will explain the issues and problems consequences to me as the client but more importantly to the individual at the time. He is always willing to go the extra mile.”

    — Senior Director of Quality, Multinational pharmaceutical company