“Paul Graham Pharma Consulting trained our staff in preparation for the first U.S.-FDA inspection in our contract laboratories. With the assistance of Paul Graham the U.S.-FDA-inspection ran very smoothly and successfully. We are very grateful for that. We are very satisfied with the prompt communication, the excellent service and the convincing GMP-knowledge during the whole process.”
Dr. Dirk Freitag-Stechl, M.B.A., Managing partner, CUP Laboratorien Dr. Freitag GmbH
“As Sunovion Pharmaceuticals Europe Ltd are now operating under our new Wholesale Distribution Authorisation I would just like to take this opportunity to thank you for all your valuable assistance in this project. The process from scope selection, through quality system build, training and to final inspection assessment was extremely efficient with all key milestones being met. The outcome of which was our successful MHRA GDP inspection and granting of the authorisation at the start of this year. I will certainly be back in touch if I require additional support in the future.”
Ian Williams, Quality Director, Sunovion Pharmaceuticals Europe Ltd
“Paul has been performing consultancy work for Circassia for over five years, performing GMP audits of all our manufacturing suppliers and providing advice on many areas as and when required.
I have accompanied Paul on a number of the audits where he is excellent at probing a situation until he has enough information to make a decision on whether this is a risk to our business. Even during difficult audits Paul remains calm, polite and very professional and is therefore able to provide an excellent assessment of each company. He can when required be direct and forceful with our clients.
Paul’s advice and help is always pragmatic and useful. He always listens to our point of view and is happy to explain the reason for his advice or to suggest ways that we can adapt the route we wish to take but remain compliant and to point out the risks. Always allowing us to make our own decisions.
At the end of last year Paul, prepared and delivered a training session on risk management, this was very well received by all, especially the workshop which re-enforced the theory. During the workshop all participants enthusiastic engaged in the task”
Heather Wells – Quality Director,Circassia
“We were very satisfied with the prompt communication and excellent service you provided us while carrying out the audit (of our API manufacturer).”
Head of Chemistry, TopiVert Pharma Ltd.
“Paul Graham Pharma Consulting delivered a ‘GMP Auditor Training’ course tailor-made to our requirements.
The training was very professionally delivered across the whole experience from training materials, delivery style, confirmation of understanding and follow up.
Each delegate was provided with a comprehensive take home folder with training materials and addition relevant information. The day comprised clear presentations with relevant break-out sessions to prompt discussion. The personal tailoring of the training meant that we could focus on areas most relevant to us within our business, and the tutor worked with us to ensure we got the most out of the day.
We took a comprehensive quiz at the end of the session to test understanding of the delegates. These were returned, graded and with certificates of completion within a few weeks of the training course. Overall it was a very positive training experience and I would not hesitate to recommend PGPC for training of this type.”
Claire Churchouse, GMP QA Manager, Covance Laboratories
“Paul Graham Pharma Consulting provided and excellent service in preparing the organisation for a FDA pre-approval inspection, leading to a successful outcome and recommended product approval.”
Dave Sanson, Quality Director, Penn Pharmaceutical Services Ltd
“Paul is extremely knowledgeable with significant expertise in Quality Systems. He has carried out GDP audits on behalf of Quality Context and applied his skills in a very organised, systematic and pragmatic way. He took on board all of our requirements and ensured that compliance needs were met at all times. He worked to an excellent standard, delivering a comprehensive audit report in a timely manner and following up with the site to obtain and acceptable CAPA response. He was flexible, adaptable, trust-worthy, hard working and a pleasure to work with.
I can wholeheartedly recommend Paul to carry out any GMP/GDP audits and would happily recruit him again in the future to carry out audits on my behalf.”
Kate Krachai, Director, Quality Context Limited
“Without Paul’s assistance we probably would not have achieved our marketing authorisation. He offers encouragement, advice and leadership where necessary. Paul played an active role in the team, despite being only a consultant. He is realistic in his expectations and delegates only where necessary. I would recommend Paul to any organisation that needs support in their pharmaceutical operations”
Gordon Lyon, Managing Director, CSTS Ltd
“Mr Graham works with Newcastle University’s Faculty of Medical Sciences providing a significant contribution to Masters teaching and professional development advice for doctoral research students. Mr Graham’s wealth of experience and assured delivery offers students invaluable insights into Good Manufacturing Practice, Quality Assurance Processes and operating to International Standards. The expert guidance offered ensures postgraduate students are equipped with an understanding of the bioscience industry that would otherwise be impossible to deliver.”
Dr Richy Hetherington, Postgraduate Development Co-ordinator and Science of the Biotechnology Industry module leader (MRes)
“I had known of Paul through his involvement on the management committee of the Pharmaceutical Analytical Science Group (PASG), his time at Specials Clinical Manufacturing and a number of personal referrals. Based on his extensive experience of sterile manufacture during clinical development and for commercial purposes, Paul is the ideal person to support us through our development programme with a view to gaining a releasing license for clinical and commercial products in the future. Paul has performed quality audits at our API and product manufacturing sites, has performed gap analysis with respect to our existing quality system, input into critical SOPs and provided guidance on quality risk assessment, an area in which he specialises.”
Dr Paul Laidler, Vice President of Pharmaceutical Sciences, Circassia Holdings Limited
“We have been delighted with the help and support that Paul has provided in his capacity as Responsible Person on our Wholesaler’s dealers Licence. He has helped write SOPs, conducted high quality staff training, and guided us successfully through an MHRA inspection. We have total faith in his knowledge and overall competence, and we have all enjoyed working with him as part of the team.”
Nick Stevens MD, Imaging Equipment Ltd
“Paul is highly experienced, pragmatic and flexible: just what you need in a contract QP. He demonstrates the highest standards and is key to making continuous improvements of our QMS. I wouldn’t hesitate to recommend him.”
Quality Director of a Major International CMO
“… Paul’s technical knowledge combined with his QP experience proved invaluable throughout the project. His advice was always constructive, clear and responded to queries in a timely manner. He was very supportive and up to date with current regulations which helped us through the critical phases. Paul was professional and courteous at all times and is highly recommended.”
Director of Quality, UK Biotech CRO
“I have every confidence in the decision making of Paul Graham. He provided excellent advice following his QP review of our first IMPD. He is pragmatic in approach with timely communication throughout the project.
In addition, he displayed good problem solving skills during the project’s development phase.”
VP of Product Development, UK Drug Delivery Company
“In his previous position of Specials Clinical Manufacturing, Paul oversaw the GMP manufacture of my company’s products from formulation development through to Phase I and Phase II clinical trial in three European countries. I have found Paul to have good knowledge of the requirements coupled with a pragmatic approach and a wealth of industry knowledge. He’s also very easy to talk to !”
Head of Quality Assurance and Regulatory Affairs, Drug Delivery Company