Risk evaluation and Impact assessment

Total Delivery Pharma (TDP), is your dedicated partner for risk evaluation and review tailored specifically for pharmaceutical, medical device and medical technology manufacturing and distribution practices (GMDP), as well as clinical research in compliance with Good Clinical Practice (GCP), Good Laboratory practice (GLP) standards. Our team is committed to addressing the intricate landscape of regulatory requirements that are constantly changing. Indeed, we support our clients to understand the impact Risks and address the Impact and how to best meet the various regulatory requirements. 

We will help you to ensure that your organization remains compliant and well-prepared for any regulatory challenges, risk is identified, and mitigations documented and in place that rigorously and robustly mange these changes.

Our services include:

Risk Evaluation and Assessment

We offer comprehensive risk assessment services tailored to the specific needs of pharmaceutical, medical device and medical technology manufacturing, distribution, and clinical research. Our team of experts utilizes industry best practices and regulatory guidelines to identify, evaluate, and prioritize risks associated with your operations.

Risk Review and Mitigation Planning

Our services facilitate efficient risk review processes, streamlining the identification of potential issues and the development of mitigation strategies. We understand that risk mitigation planning is often complex and time-consuming, which is why we provide tools and resources to simplify the process and ensure thorough risk management.

Compliance with GxP Standards

We help organizations align with GxP standards to ensure the quality, safety, and efficacy of medicinal products for human use. Our platform provides guidance on implementing GxP principles and maintaining compliance with regulatory requirements.

Data Integrity Assurance

Data integrity is critical in pharmaceutical medical device manufacturing and clinical development and research. TDP offers evaluation of your process and helps to ensure the integrity, reliability, and accuracy of data throughout the product lifecycle, in accordance with regulatory expectations.

Regulatory Updates and Monitoring

We keep you informed about the latest regulatory developments, including updates from EMA, FDA, MHRA, ICH, MDSAP, PIC/s, WHO and worldwide regulators, and other non-regulatory bodies. Our team provides timely alerts and expert analysis to help you navigate regulatory changes effectively. Providing updated training tailored to meet your needs as well as comprehensive targeted review of process and procedures.

Adverse Inspection

Our experienced team can help you address a regulator's concern and present a robust response that is achieve and deliverable. We can support you through the remediation process and successfully re-establish full compliance within the GMDP, ISO 13485, GLP, GCP and GCLP sectors.

At TDP, we are committed to supporting pharmaceutical, medical device and medical technology organizations in meeting regulatory requirements, mitigating risks, and maintaining the highest standards of quality and compliance. Contact us today to learn more about how our platform can benefit your organization.

Book a 30 min consultation to discuss your needs.

Recent notable updates that we have supported clients with include: 

  • EudraLex Volume 4, Annex 1, EudraLex Volume 4, Annex 21  

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Including ICH E1, ICH E10, ICH E11, ICH E15, ICH E16, ICH Q14, ICH Q2(R2) 

  • FDA: Data Integrity for In Vivo Bioavailability and Bioequivalence Studies 

  • FDA: Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry: Guidance for Industry 

  • FDA: Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards 

  • EMA: Reflection paper on the use of artificial intelligence in the lifecycle of medicines 

  • EMA: Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples 

  • EMA: Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials 

  • EU: Artificial Intelligence Act 

  • EU: Reflection paper on Good Manufacturing Practice and Marketing Authorization Holders

 

 AFFILIATIONS

CLIENT FEEDBACK

  • “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

  • “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 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

  • “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

  • “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