Pharmaceutical GMP & GxP Consultancy
From Action Plan to Implementation
Resolve pharmaceutical quality and compliance problems through clear assessment, practical implementation and documented checks of effectiveness.
Paul R Palmer Limited provides pharmaceutical GMP and GxP consultancy, Qualified Person support, inspection remediation, Pharmaceutical Quality System development, deviation and CAPA support, site licensing, auditing, microbiology support and professional training.
Our approach connects assessment with implementation and verification rather than stopping at recommendations.
1986
Pharmaceutical Experience
Since 1986
2004
Qualified Person
Since 2004
1998
Lead Auditor
Since 1998
✓
Academic Qualifications
DBA · MBA · MSc Quality Management
GMP & GxP Resources
Understand GMP and GxP Requirements
Access practical educational resources explaining the major Good Practice frameworks used across the pharmaceutical and life-sciences sectors.
GMP-Good Manufacturing Practice
Understand the principles, systems and controls used to ensure medicinal products are consistently manufactured and controlled to the required quality standards.
cGMP — Current Good Manufacturing Practice
Understand the meaning of current Good Manufacturing Practice and how cGMP terminology is used, particularly within the US regulatory environment.
GDP — Good Distribution Practice
Understand the requirements governing pharmaceutical storage, transportation, wholesale distribution and supply-chain integrity.
GCP — Good Clinical Practice
Understand the standards governing the design, conduct, recording and reporting of clinical trials involving human participants.
GLP — Good Laboratory Practice
Understand the principles governing the organisation, conduct, recording and reporting of non-clinical laboratory studies.
GVP — Good Pharmacovigilance Practice
Understand the systems and responsibilities used to monitor, evaluate and manage the safety of medicinal products.
GxP Data Integrity
Understand ALCOA+, metadata, audit trails, electronic records and data-governance expectations across regulated activities.
GAMP & GxP Computerised Systems
Understand risk-based approaches to computerised systems, validation, data integrity and GAMP principles within regulated environments.
Consultancy Services
What Can We Deliver for Your Pharmaceutical Business?
GMP & GxP Consultancy
Practical support to understand, implement and maintain the regulatory requirements applicable to your activities, products, systems and markets.
- GMP and GxP gap assessments
- Regulatory interpretation
- Quality-system development
- Procedure development
- Compliance remediation
- Implementation support
- Training and competence development
- Verification of implemented improvements
Inspection Readiness & Remediation
Assessment, prioritisation and implementation support before or following regulatory inspection.
- Mock inspections
- Gap assessments
- Observation assessment
- Remediation planning
- Inspection-response support
- Implementation tracking
- Effectiveness verification
Pharmaceutical Quality Systems & SOPs
Development and improvement of Pharmaceutical Quality Systems based on actual operational requirements.
- PQS gap assessments
- Quality-system design
- Process mapping
- SOP development
- Forms and records
- Management review
- Implementation support
- Training
Deviations, Investigations & CAPA
Structured support for investigations, root-cause analysis, corrective and preventive action and effectiveness verification.
- Deviation backlog assessment
- Investigation support
- Root-cause analysis
- CAPA development
- CAPA implementation
- Trending
- Effectiveness checks
Qualified Person Services
Qualified Person support for commercial and clinical medicinal products and associated pharmaceutical quality activities.
- Batch-certification support
- Batch-documentation review
- Quality-issue assessment
- API supply-chain assessment
- QP declarations
- QP mentoring
- Inspection support
Site Licensing & Operational Readiness
Support establishing pharmaceutical operations and preparing sites for regulatory assessment.
- Licensing strategy
- Readiness assessment
- Quality-system implementation
- Documentation preparation
- Operational readiness
- Pre-inspection assessment
- Remediation support
Pharmaceutical Audits
Independent assessment of pharmaceutical manufacturers, suppliers, contractors and regulated activities.
- GMP audits
- GDP audits
- Supplier audits
- Contract-manufacturer audits
- Quality-system audits
- Audit reports
- CAPA review
- Follow-up verification
Microbiology & Sterility Assurance
Specialist support for pharmaceutical microbiology, contamination control and sterility assurance.
- Contamination Control Strategy review
- Environmental monitoring
- Microbiological investigations
- Aseptic processing
- Sterility assurance
- Method and process review
- Training
- Remediation support
About our founder
Paul R Palmer
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 the 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 may be 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, is all accounted for.
Pharmaceutical Consultancy Services
Expert pharmaceutical consulting categories, custom solutions available on request.
01
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.
Read More
02
With our help and support you can achieve and maintain an inspection ready status, unannounced inspections are rare, but they do happen.
03
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.
Read more
04
Auditing of suppliers, for QP declarations, verification of EU and UK regulatory compliance, as well as maintenance audits to meet your requirements for oversight.
Read more
05
Qualified person certification in accordance with Euderalex volume 4, Annex 16 for clinical and commercial supply in the UK and throughout Europe.
06
Creation, maintenance and update of your pharmaceutical quality system for your manufacturing, supply and distribution of medicinal products.
Read more
07
Oversight of the service provision, whether that be physical or digital including agreements and oversight to ensure your needs are met...
Who are the enablers of your business?
Struggling to Integrate into your business?
We have something that can help.. Our white paper can help you get the information you need to get back on track!
Struggling With Regulatory Complexity? Get a Free Regulatory Roadmap to Fast-Track Your Product to Market
Join the 100+ pharmaceutical companies who’ve saved time, avoided costly delays, and passed inspections the first time.
At Paul R Palmer, we don’t just offer services — we clear regulatory roadblocks. Whether you’re pre-approval or post-inspection, we’ll show you exactly how to get licensed, stay compliant, and get your product to market — without the delays, chaos, or guesswork.
Here’s what’s inside your personalised plan:
- What you need (and don’t) for your first licence
- How to handle QP declarations without stress
- What regulators are really looking for during inspections
- The batch release checklist we use every time
- Audit-proof systems to keep you ready year-round
- Coaching routes to help your team go from “huh?” to “inspection ready”
What do others say
Testimonials
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.
Jane Wright
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.
Michael Burke
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
Ashley Keating
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.
Debra (Turner) Ainge
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.
Jamie Oduro
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.
Gábor Mihályi
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
Preetham Hiremat
Paul R Palmer has been in the pharmaceutical industry for over 35 years, while in school he was a dispenser in a pharmacy and has always been curious about the medicinal products being prescribed and their impact on patients. He started his own consultancy.
Copyright © 2026 Paul R Palmer. All Rights Reserved. | Design and Developed By Gatitaa Inc, Dallas, TX, US