About us

Meet our team over 125 years total experience

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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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THOMAS DENTON

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

Specialising in

  • Strategy

  • Project management

  • Validation and Compliance

  • Risk Management

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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LUCIA DALVIT

UK / EU QP Quality GMDP Expert

Specialising in

  • Quality Systems and Processes

  • Imports and Export, Compliance

  • IMPs

  • Continuous Improvement

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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