Paul R. Palmer
Paul R Palmer Limited is a pharmaceutical consultancy dedicated to providing expert support and services in the pharmaceutical industry. With over 35 years of experience, Paul R Palmer specializes in regulatory compliance, quality management, batch release, training, and innovative pharmaceutical solutions. The company aims to help pharmaceutical businesses achieve and maintain regulatory compliance, improve product quality, and implement advanced technologies in drug development and manufacturing.
Industries
Nr. of Employees
small (1-50)
Paul R. Palmer
Worthing, West Sussex, United Kingdom, Europe
Products
Batch Release Support
Professional consultancy services offering Qualified Person (QP) batch certification, review process optimization, and regulatory compliance assistance for clinical and commercial pharmaceutical supply in the UK and Europe.
Product License Support
Expert guidance and regulatory support on product license establishment, maintenance, and registration in the UK, including Brexit licensing strategies and responses to requests for further information.
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.
Inspection Support
Professional consultancy services providing regulatory inspection preparation, compliance assessments, and hosting support in the UK.
Inspection Readiness
With our help and support you can achieve and maintain an inspection ready status for rare unannounced inspections.
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.
Batch Release Support
Professional consultancy services offering Qualified Person (QP) batch certification, review process optimization, and regulatory compliance assistance for clinical and commercial pharmaceutical supply in the UK and Europe.
Product License Support
Expert guidance and regulatory support on product license establishment, maintenance, and registration in the UK, including Brexit licensing strategies and responses to requests for further information.
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.
Inspection Support
Professional consultancy services providing regulatory inspection preparation, compliance assessments, and hosting support in the UK.
Inspection Readiness
With our help and support you can achieve and maintain an inspection ready status for rare unannounced inspections.
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.
Services
Support for preparation of site licence applications and assistance through the site licence inspection process.
Preparation, hosting and remediation support for regulatory inspections including developing corrective action plans for observations.
Tailored training programmes covering GMP, GDP, QP responsibilities, CSV, auditing and other GxP topics.
Audits and oversight of suppliers and third-party manufacturers to verify GMP/GDP compliance and perform maintenance audits.
Qualified Person services for commercial and clinical batch release, batch review process optimisation and GMP compliance review.
Review, creation and optimisation of quality management systems to ensure compliance during manufacture, storage and distribution.
Support for preparation of site licence applications and assistance through the site licence inspection process.
Preparation, hosting and remediation support for regulatory inspections including developing corrective action plans for observations.
Tailored training programmes covering GMP, GDP, QP responsibilities, CSV, auditing and other GxP topics.
Audits and oversight of suppliers and third-party manufacturers to verify GMP/GDP compliance and perform maintenance audits.
Qualified Person services for commercial and clinical batch release, batch review process optimisation and GMP compliance review.
Review, creation and optimisation of quality management systems to ensure compliance during manufacture, storage and distribution.
Expertise Areas
- Regulatory compliance and inspection readiness
- Batch release and Qualified Person (QP) certification
- Pharmaceutical Quality Management Systems (PQMS)
- GxP / GMP / GDP training and competency development
Key Technologies
- UV-Vis spectroscopy
- NMR spectroscopy
- Infrared (IR) spectroscopy
- Analytical chemistry methods for purity and stability assessment