Naresh Renikindi

Naresh Renikindi - Total Delivery Pharma

  • Making a positive difference to patient life through the pragmatic solutions in the manufacturing and distribution area of medicines continuously motivates me and provides profound personal satisfaction.

  • I am a UK/EU Qualified Person and Responsible Person/ Responsible Person (import) with over eighteen years of experience in Quality Assurance, Quality Control, Production, Auditing, Validation, Regulatory Affairs, and Distribution of Pharmaceuticals, Medical Devices, Borderline Products, and Combination Products.

    My expertise spans both clinical and commercial environments, as well as small and large molecules globally. I have hands-on experience with various dosage forms, including the latest mRNA vaccines and CAR-T cell therapies. In addition to routine batch releases, I have designed and led numerous projects from Phase I to commercialisation. I am also experienced in developing new manufacturing and wholesale distribution licenses. As a specialist risk-based auditor, I have conducted over 250 audits worldwide, covering the full spectrum of GMDP operations. This includes multiple mock audits, PAI audits, due diligence audits, and leading several MHRA/USFDA remediation projects, such as developing Annex 1 cross-contamination compliance, data integrity, cleaning validation, and redesigning QMS.

    • Actively supported batch releases as QP and also as RP in both the UK &EU for multiple clients in both clinical and commercial environments

    • Led over 150 audits across globe as an Independent Consultant

    • Developed seven new MIA/WDA licenses including transition of QMS from Clinical to Commercials

    • Four remediation projects in MHRA & USFDA environments

    • GMP design of IMP

    • Lead multiple GMP and QMS implementation projects

 AFFILIATIONS

CLIENT FEEDBACK

  • “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

  • “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