Gap Analysis

Total Delivery Pharma is your trusted partner for pharmaceutical and medical device quality compliance solutions.

We specialize in providing comprehensive services tailored to meet the stringent regulatory requirements of the pharmaceutical and healthcare industries. We leverage ICH Q10 to ensure that we not only provide reporting on the gaps in your QMS but provide detailed risk analysis and we will help you develop objective Corrective actions and identify possible preventive actions and opportunities for improvement.

Good Manufacturing Practice (GMP)

We offer expert GMP compliance assessment and gap analysis, ensuring that your manufacturing processes meet the highest standards of quality and safety. Our services cover GMP requirements outlined EU GMP and UK GMP, and US GMP FDA CFR 210/211. We have created detailed gap analysis process for with recent updates such as:

  • EU GMP Eudralex Volume 4 Annex 1,

  • EU GMP Eudralex Volume 4 Annex 21,

  • US GMP FDA Drug Supply Chain Security Act (DSCSA). 

  • Our specialist knowledge in ATMPS & Biologicals allows us to not only support Part I, Part II and III but also Part VI of EudraLex - Volume 4 guidelines. 

Book a 30 min consultation to discuss your needs.

API Distribution and Manufacturing

Leveraging ICH Q7, US FDA: 21 CFR 210 and 21 CFR 211, EU GMP Part II standards and 2015/c 95/01, US Drug Quality and Security Act we apply our expertise to perform gap assessments of API brokering, distribution and manufacturing, ensuring compliance with regulatory standards for quality control and documentation.

Book a 30 min consultation to discuss your needs.

Finished Product Compliance

We help navigate the complexities of compliance for finished products, adhering to FDA 21 CFR 210, 21 CFR 211, 21 CFR Part 11, 21 CFR 600 and EU GMP Part I, Part III, Part IV and relevant annexes and associated guidance to ensure product safety and efficacy. 

Book a 30 min consultation to discuss your needs.

Consumables and Excipients

Our Gap assessment services extend to consumables and excipients, ensuring Quality systems can consistently maintain ExiPact standard and ISO 9001 standards to ensure the quality and integrity of materials used in pharmaceutical manufacturing. 

Book a 30 min consultation to discuss your needs.

Laboratory Quality Control Testing

Our laboratory Gap Assessment services ensure that your Quality System is complete and been consistently and effectively implemented ensuring quality control testing to GMP standards, utilizing ISO 17025 guidelines to ensure accurate and reliable test results.

Book a 30 min consultation to discuss your needs.

Sterilization and Aseptic Manufacturing

We provide detailed gap assessment to health care product manufactures completing QMS and process evaluation to ensure compliance with sterilization and aseptic manufacturing processes (ISO 11137/ISO 14937) standards to maintain product sterility and safety. 

Book a 30 min consultation to discuss your needs.

Medical Device Compliance

Our gap analysis services cover ISO 13485 and the Medical Device Single Audit Program (MDSAP), offering unified international standards for medical device auditing to ensure regulatory compliance and product quality. 

Book a 30 min consultation to discuss your needs.

Clinical Trial Compliance

We help review compliance of your Quality management system to ICH E6 guidelines for clinical trials, ensuring the integrity and reliability of data collected throughout the trial process. 

Book a 30 min consultation to discuss your needs.

Food Safety Standards

With expertise with ISO 22000 quality standards for food-grade materials, we will help you with borderline substances, ‘Nutriceuticals’ and fortified foods we will help you identify the gaps and improvement options. Ensure your QMS is fit for purpose, effective and working optimally. We will use our expertise to pragmatically effectively improve your processes. 

Book a 30 min consultation to discuss your needs.

We use a simple 6 step process:

  • Discovery Call

    • Confirm Mutual Fit

    • Confirm Standards

    • Confirm Timelines

    • Confirm Project Pricing

  • Off-Site Document Review & Assessment

    • Access to Remote Repository

    • Review QMS and Supporting Documentation

    • Onsite Plan and Agenda

  • On Site Compliance and Process Review

    • On Site Review

    • On Site Process Evaluation

    • On-the-Day Debrief

  • Exception Reporting

    • Summary of Gaps

    • Compliance Risk

    • Opportunities for Improvement

  • Debrief Call

    • Review of Items

    • Confirmation of Action Items

    • Outline CAPA

    • Initial Timeline

  • CAPA Proposal

    • Collaborative CAPA proposal

    • Action Plan Preparation

    • Evidence review and Implementation support

Contact us

 

 AFFILIATIONS

CLIENT FEEDBACK

  • “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

  • “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

  • “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

  • “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