Pharmaceutical Consultancy Services
Expert pharmaceutical consulting categories, custom solutions available on request.
Site license support
Helping you prepare for your application and supporting you and your team through the inspection process to ensure your approval for a new site licence.
Inspection readiness
With our help and support you can achieve and maintain an inspection ready status, unannounced inspections are rare, but they do happen. I you ready?
Specialist Training
We provide routine and best practice training to ensure you and your team have the skills you need to deliver optimum performance. This can be customised to meet your requirements.
Supplier Auditing
Auditing of suppliers, for QP declarations, verification of EU and UK regulatory compliance, as well as maintenance audits to meet your requirements for oversight.
QP Batch Release
Qualified person certification in accordance with Euderalex volume 4, Annex 16 for clinical and commercial supply in the UK and throughout Europe.
Pharmaceutical Quality Management System
Creation, maintenance and update of your pharmaceutical quality system for your manufacturing, supply and distribution of medicinal products.
Computer Systems Validation
Training and done for you services in the preparation of and review and implementation of the quality oversight function for your business relating...
Subcontracting Services
Oversight of the service provision, whether that be physical or digital including agreements and oversight to ensure your needs are met...
About our founder Paul R Palmer
Paul R Palmer's profile and experience
Paul R Palmer has been in the pharmaceutical industry since 1986, he has accrued over 60,000 hours of experience in the development manufacture and supply of medicinal products and medical devices.
Throughout his career Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use optimise and enhance efficiency. Starting with biology has resulted in a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around them with a curiosity that is rarely satisfied.
Working with Paul, you may find challenging as he pushes your systems and processes, further than you thought was possible.
Benefit from the services of a contract Qualified Person
At first you may think this is simply to perform the batch release function. When a Quality professional such as Paul Palmer or one of his colleagues works with your business, you can be sure to benefit more from the vast experience brought to the role.
Available support for all medicinal product dosage forms
Paul Palmer has been eligible to act as a Qualified Person under the permanent provisions since 2004. Support is available for all medicinal product dosage forms and if required their associated medical devices.
Experience in solid dose, liquids and creams
Experience across the board in solid dose, liquids and creams, non-sterile and sterile terminally sterilised or aseptic manufacture as well as biological products and radio pharmaceuticals are all accounted for.
Sign Up Here To Get A Coherent Plan For How To Get Your Product To Market
At Paul R Palmer we find our clients benefit from the flexible approach we have to providing the resources they need to maintain regulatory compliance. There are a range of services we offer pharmaceutical companies individually or as a combined package. We can help you with:
- Getting your first license
- QP declarations for API manufacturers
- Hosting a regulatory inspection
- Commercial and clinical batch release
- Carrying out compliance audits
- Coaching and training in GxP
TESTIMONIALS
What do others say
Jane Wright
I was extremely impressed by Paul's approach during an MHRA audit a few months ago. As well as being extremely good with the auditors and explaining processes with gravitas, he was excellent with the support team. Audit requests were concise and relayed calmly and Paul's interpersonal skills really helped in getting the best out of the audit team.
I've seen a lot of quality managers with a variety of styles during regulatory audits, some good, some bad but none anywhere near as good as Paul.
Michael Burke
I have worked with Paul for several years in his roles as QP and Quality Director. He has an excellent knowledge and is highly professional. I would definitely recommend Paul and would happily work with him again.
Ashley Keating
During Pauls tenure at Biogen Idec he provided an invaluable insight into UK and EU GMP regulations and pushed through several key initiatives within tight timelines. Pual worked particularly well with our UK regulatory group and provided a key link between this group and our European Quality groups
Debra (Turner) Ainge
Paul joined Clinigen initially as a contract QP with a view to supporting the Quality Team with his extensive knowledge and experience. Six months in the Global Quality Director resigned due to personal reasons and Paul stepped into the role at short notice. This was really important to the company as we were expecting 2 MHRA inspections. With Paul taking the lead in preparations, management and hosting the inspections we achieved excellent results, including the site under close monitoring achieving which received the best result in years.
Paul has a pragmatic approach to any role he takes on, drawing on his extensive knowledge and experience to achieve the best possible result for the company while maintaining compliance.
Jamie Oduro
Paul’s knowledge and experience in the pharmaceutical industry is secondary to none. He is highly recommend for all aspects of pharmaceutical manufacturing, management and had extensive auditing experience. As a busy QP he is always finds the time to support and mentor me where possible.
Gábor Mihályi
I have worked with Paul on multiple occasions and if you turn to him with any business related or other issues, he sure will help you! He has not only a strong GMP, GDP and other GxP background, but also experience and strong knowledge of the wider business processes. I like working with him as I can learn a lot, and doing so in a fun and entertaining environment. He has a good sense of humour and a good personality, balancing being serious, experienced, knowledgeable and fun in the right way.
Preetham Hiremat
Paul came on board Brown&Burk to support the team in our growth. He has provided complete support to the entire team to enhance their capabilities and in ensuring compliance to various changing regulations.
Paul is very quick to adapt and implement new technologies.
One among the selected few QP’s in UK who are technologically savv