Schwerpunkte und Leistungen
With more than 25 years of real-world experience in the nonclinical/GLP/GCLP quality business, I am able to provide professional support and advice in the following areas
- Strategic guidance and oversight of GxP functions – staffing, organization, strategy, etc.
- Training and coaching of QA staff, technical staff, study directors and quality managers
- Inspection Readiness Support: Preparation for inspections by GLP Monitoring Authorities from Europe and from the US, including support during the inspection, based on the experience of more than 20 of these inspections (10 from US FDA)
- Support with CRO inspections globally (Europe, North America, China, India) for GLP compliance. I have in depth knowledge regarding the compliance status and the technical capabilities of many CROs. This also includes GCP compliance of laboratories („GCLP“)
- Developing and implementing of GLP compliant quality systems
- Developing and implementing of GCP compliant quality system in laboratories (“GCLP”)
- Developing and implementing quality systems in non-regulated research areas
- Analysis of existing quality systems and advice for optimization
- Computer System Validation guidance and support
- Support with GLP compliant closure of established GLP sites
- Review of all types of GLP-relevant documents
- Inspection of CROs and animal breeders for compliance with AAALAC guiding principles
Quality on demand. Compliance assured.
Regulatory compliance is a key success factor of any submission to health authorities worldwide. Over the past decade, regulatory requirements, as well as expectations of the GxP monitoring authorities with regard to patient safety and to animal welfare, have increased, leading to changes in the design of nonclinical and clinical studies; one example is the increased use of biomaker analyses in clinical trials. There are many possibilities for additional study endpoints that can be considered relevant for your molecule.
As a result, it is very important for you to find the right partner to help you manage compliance issues. The proper partner can support you minimize the risk of unnecessary failure and find the right path to compliance.
We at LehnConsulting have the know-how and the expertise to deliver high quality solutions. As specialists in the field of regulatory compliance and quality, we provide a comprehensive set of services of customized on-site and global support to help you achieve a successful marketing authorization. This will not only ensure compliance, but will also minimize resource requirements, thereby saving you valuable time and money.
We have the passion to make the difference!
All references listed exclusively relate to the former roles of Hermann Lehn as employee of pharmaceutical companies. For each reference listed, the written approval for publication on this website is on file.
Vice President, Global CRO
Hermann is a great expert in regulatory toxicology with international reputation and deep knowledge of GxP environments around the globe. I have known Hermann for almost 30 years, and it has always been an extremely constructive relationship with a clear focus on goals and outcomes.
Vice President, Global CRO
I have worked with many Sponsors and Consultants during my 30 years in Contract Research. In all that time, I’d have to rate you as the best Sponsor representative I’ve ever had the pleasure to collaborate with. You did a great job for your company, but always made the relationship with us feel like a true partnership, which in turn meant that we always endeavoured to do our best in return. From a QA perspective, your involvement with international regulators and knowledge of their respective expectations was always apparent in our discussions ... so when you raised an issue with us, we knew it was something we needed to address!
Vice President, Global CRO
Hermann has invaluable insights gained from his experience in drug development, people leadership, strategic planning and quality. Importantly, he has a deep understanding of the practical aspects and challenges of drug development and how to apply the regulatory guidelines to ensure quality. In my role as a leader in a major CRO, Hermann sets the benchmark.
Senior Vice President, Big Pharma
I know Hermann Lehn since many years and we have been working together for quite some time. I was always impressed by his regulatory expertise and his deep understanding of processes in PH R&D combined with his professionality and pragmatism in managing complex topics. His sound judgements were the ones I always relied on.
Vice President, Global CRO
I always found it a pleasure to work together with Hermann as he fully understood and appreciated the benefits of a true partnership. Communications were always direct, fair, and with understanding of the the challenges and opportunities being addressed. Commitments were always delivered upon. Finally, Hermann brought a level of experience and integrity that benefited both parties in the relationship.
Senior Vice President Global CRO
I am so sorry to see you leave Roche, but I am very happy for you as you start your next chapter. You will be very successful as a QA consultant; you would be at the top of my list to call! Thanks again for the wonderful partnership and the many times you offered wise counsel to me.
Senior Quality Manager Big Pharma
I have been working with Hermann for more than 10 years, we were covering different aspects of a Quality. Hermann was an absolute specialist in his field but he was always open and keen to look into adjacent fields of Quality, too. Together, in our team of the 4/5 global Quality Leaders we made great progress towards a general Quality sytem spanning all areas relevant to pharmaceutical activities. In addition, Hermann was very easy to work with, an open positive personality with good humour.
Global Business Manager, Big Pharma
It has been a pleasure working with you over the last few years. It is seldom that I meet people who are true gentlemen, especially when under pressure, but you are one. I very much appreciated your wise and open council, and will miss this going forward.
Global Quality Manager, Big Pharma
I have worked with Hermann at a major pharmaceutical company for many years and recognize him as an expert in quality assurance with emphasis in the GLP area. He has overseen the quality assurance groups on a global level interacting with local organizations in the US, Europe and Asia. He has successfully handled both FDA and Swissmedic inspections of GLP test facilities. He always provided knowledgeable and practical guidance to ensure that our sites operated in a compliant manner with regard to non-clinical studies and computer system validation.
Business Manager, Global CRO
Have known Hermann for approximately 10 years having interacted with him in a few of the various roles he has filled including outsourcing of Toxicology and Metabolism studies; managing Toxicology studies; and Compliance/QA. What has always impressed me the most is his ability to sort through a multitude of items and focus on the ones that are critical. For example, when inspecting a laboratory, one will likely always find “something”, however Hermann has the ability to immediately identify what is a critical issue vs the minutia that do not impact compliance. He is always able to find the right balance.
In addition, always appreciate his candor, he delivers both praise and criticism clearly and appropriately which is a reflection of professionalism.
Vice President Quality, Big Pharma
I had the privilege to work alongside Dr. Hermann Lehn for many years in a number of different GxP capacities (audits, inspections, qualifications) throughout the world (US, Asia, Europe); I always found him to be professional, engaging, partnered, educating, competent, succinct, strategic, rational, calm, and even entertaining, sometimes! He truly is a delight to work with; five stars! Highly recommend!
QA Manager, Big Pharma
Dr. Lehn is a regulatory professional of the highest caliber. I have known Hermann for almost 15 years, he has a unique set of skills, he is as familiar with the US FDA Regulations as he is with the EU OECD Guidance’s. Dr. Lehn is also well versed in the Asian regulatory areas especially China and Japan. He takes a very pragmatic approach to solving complex problems. Hermann has dealt with US FDA Regulators and with EU/OECD Health Inspectors, and has had an equally favorable rapport with both. Hermann is very adept at working in a corporate culture, he understands the importance and complexities of succeeding in a regulatory environment. I would strongly endorse Dr. Lehn as a consultant to the regulated environments of the Pharma and BioPharma industries.
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LehnConsulting in Leverkusen ist in den Branchen Pharma Unternehmen und Coaching, Consulting und Beratung tätig. Hermann Lehn, PH.D. (Founder & Quality Consultant at LehnConsulting) leitet das Unternehmen.