Pharmaceutical Consultancy Services
Expert pharmaceutical consulting categories, custom solutions available on request.
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.
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?
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.
Creation, maintenance and update of your pharmaceutical quality system for your manufacturing, supply and distribution of medicinal products.
Auditing of suppliers, for QP declarations, verification of EU and UK regulatory compliance, as well as maintenance audits to meet your requirements for oversight.
Qualified person certification in accordance with Euderalex volume 4, Annex 16 for clinical and commercial supply in the UK and throughout Europe.
Training and done for you services in the preparation of and review and implementation of the quality oversight function for your business relating to production, processing, cleaning and qualification of equipment and facilities.
Oversight of the service provision, whether that be physical or digital including agreements and oversight to ensure your needs are met and issues are resolved.
About our founder Paul R Palmer
Paul R Palmer's profile and experience
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.
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 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.
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What do others say
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.
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.
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.
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.
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.
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