Flexible expertise when you need it
Dr Michael Gamlen – Pharmaceutical Consultant
Managing Director and founder of PDS
- Expert in outsourcing all aspects of product development
- Specialist expertise in particle science and particle size analysis
- Responsible for product development of wide range of new drugs currently on the market
Michael has over 30 years experience of tablet development. He specialises in managing product development, formulation, tablet and process development studies.
He was Head of Tablet Development at the The Wellcome Foundation for 15 years, and has since worked for Vanguard Medica and as a consultant.
Awarded a First Class Honours degree in Pharmacy, specialising in Pharmaceutical Engineering, he studied for his PhD at Nottingham University.
Paul Cummings – Director of Pharmaceutical Development
Dr Paul Cummings is a Pharmaceutical Consultant with nearly 30 years experience in Pharmaceutical R&D specializing in sterile / parenteral product development including product formulation development, development plans, contamination control, strategic assessments, due diligence activities, specialist auditing of parenteral facilities to cGMP, troubleshooting, microbial contamination and design of parenteral manufacturing facilities.
He spent 24 years at GSK in various technical roles including Director Pharmaceutical Development. Paul is a Chartered Biologist and a Fellow of the Society of Biology and is an expert in pharmaceutical radiation safety, ADME study design and implementation. He has vast regulatory experience with European and FDA agencies and authorship of numerous regulatory submissions including INDs, NDAs, aNDAs, MAAs and CTXs. A proven track record for teaching, mentoring and coaching with many years managerial experience at all levels.
Cinzia Boldarino – Regulatory and Medical Devices Consultant
Cinzia has over 20 years experience in the pharmaceutical market; advising on complex medical device classification queries, CE marking and all aspects of Regulatory Affairs for medicinal products in the European Union.
Cinzia works with clients to support their regulatory and local pharmacovigilance needs. Regulatory support often includes devising a suitable regulatory strategy, submission and maintenance of licences, CMC activities, updating dossiers, gap analysis and due diligence.
Hedley Rees – Supply Chain Management
Hedley is managing director of PharmaFlow Limited and had many years in the pharma and biotech industry working with high profile biotech and emerging specialty pharmaceutical companies to bring new ‘molecular’ entities and re-profiled compounds through development stages into full scale commercial launch. He has been a key contributor to trial progression and commercial launch across all phases of development in multiple territories and global markets.
Hedley was responsible for managing global supply chains in big pharma companies such as Bayer and Johnson & Johnson. Here, he built a wide competency base in all the disciplines of supply chain management, implementing and using state-of-the-art information systems enablement. He holds an Executive Master’s in Business Administration from Cranfield University School of Management, a degree in production and industrial engineering from the University of Wales and is a full corporate member of the Chartered Institute of Purchasing and Supply (CIPS). Hedley sits on the Bio Industry Association’s Manufacturing Advisory Committee and has previously lectured strategic supply chain management for the CIPS professional stage examinations.
Brian Matthews – Medical Devices and Regulatory Affairs Consultant
Brian is a highly experienced Medical Devices and Regulatory Affairs consultant. He’s published numerous articles and contributed to several books and lectures worldwide on regulatory topics.
He was involved in the production of the British Pharmacopoeia and the British Pharmacopoeia (Veterinary), and the development of technical standards and test procedures for natural products, pharmaceutical forms, antimicrobial preservative efficacy, sterilisation procedures and plastics containers. He also provided support for the UK delegation to the European Pharmacopoeia Commission.
His experience includes concertation and centralised procedures, multistate and mutual recognition procedures; CE marking design dossiers and technical file preparation; appeals at CPMP and national level (EU); European and International standards work.
He recently provided regulatory strategic advice for pharmaceutical products and medical devices. Other services included monitoring of medical device sector re intraocular devices and contact lenses/care products, sterilisation methods, braille for pharmaceutical labelling and preparation of expert reports for arbitration cases (pharmaceuticals).
Brian earned his B Pharm (Hons) and PhD in Pharmaceutics at Chelsea College, University of London.
Dr Carole Malcolmson – Quality and Regulatory Affairs consultant
Carole is a dedicated professional with broad experience in the pharmaceutical, nutraceutical and animal sectors. She has worked for large multi-nationals, small aspiring companies, tertiary institutions and government organisations. She has worked independently, as part of a team and as a leader of teams and in companies that have carried out their own manufacturing as well as others that manage outsourced contract organisations.
Carole brings experience in quality assurance, pharmaceutical development and regulatory affairs, an outstanding academic record in science and management and excellent communication skills.
Key achievements include:
- External evaluator for Medsafe NMA intermediate risk (generic) submissions
- Interim Head of Quality and Regulatory Affairs for a biotechnology company
- Update of a European DMF for an active pharmaceutical ingredient for veterinary use
- Review of supplier DMFs for veterinary active pharmaceutical ingredients
- Application to the European Directorate for Quality of Medicines (EDQM) for a certificate of suitability for a bovine blood-derived product
- Pharmaceutical development report writing
- SOP writing
- GMP facility audit on behalf of an overseas client
- Workplace GMP training for a distribution company handling related products
- External lecturer on pharmaceutical research and development, drug regulation and advertising of drug products in New Zealand (University of Auckland Pharmacy 111G)
- External lecturer for post-graduate Pharmacy 752 Pharmaceutical Quality Assurance, University of Auckland
Carole earned her PhD at King’s College London and studied for her MBA at Henley Management College, UK. She also has an MSc in Pharmaceutical Technology, with distinction from King’s College London, UK and a Diploma in Pharmacy, with distinction from CIT, New Zealand.
Paul Butler – Associate Pharmaceutical Consultant
Paul has over 20 years experience in pharmaceutical and toiletries production. He’s travelled widely as a senior consultant, working on assignments in Ireland, Europe, Africa, Australia and The Middle and Far East.
His years in pharmaceutical production have given him a firm base for providing a pragmatic service based on operational experience.
His key skills include:
- Project definition
- Site strategy and planning
- Conceptual design and specification
- Designing for containment
- Equipment specification
- Project management
- GMP auditing – API & secondary
- FAT & SAT witnessing & supervision
- GMP training
- Design and supervision of installation of new suite for tablet manufacture
- Factory modernisation and implementation of computer-assisted materials management project
- Production, materials management, and engineering services
- Advising international companies on all aspects of GMP compliance, facility and equipment design and specification to meet production objectives and regulatory compliance. Many projects involved designing for high levels of containment. Also worked on validation of a number of these facilities
- API auditing to ICH Q7 standards as well as GMP training
Paul earned his BSc (Hons) at the University of Hertford
Martin Slade – API Consultant
Martin has gained extensive experience in API process development and scale-up/technology transfer to GMP requirements, and the design and construction of plants to make APIs.
He’s travelled extensively, visiting many API factories worldwide to conduct audits with reference to ICH Q7 guidelines. He has an in-depth knowledge of Indian API producers and API sourcing and auditing in China.
He’s held many senior API audit positions and his work has included:
- Organisation of audit schedules including dosage-form as well as API
- Conducting audits on behalf of client’s PharmAssess auditing scheme
- Production of reports presentations at agreed symposia, meetings and exhibitions
- Liaising with Regulatory Authorities
- Updating clients on regulatory requirements for APIs
- Building and maintaining database of clients and suppliers
- Advising on budget setting and control
- Setting up and running a Physical Properties Laboratory to investigate polymorphism in APIs. (Instrumentation included mid and near IR, XRPD, DSC, TGA)
- Undertaking excipient/active interaction studies in support of the formulation departments
- “Troubleshooting” problems occurring in API processes and dosage-form formulations
Martin earned his BSc in Chemistry at the University of Kent at Canterbury and his MSc (in Organometallic Chemistry) and DPhil at the University of Sussex.
He also holds ISO 9000:2000 Series and PS 9000/PS 9100 Auditor 2004 (Lead Auditor 2008)
Philip Rabone MSc CChem MRSC – Analytical Consultant
Data integrity auditing in manufacturing and product development
A task orientated strategist, who will establish the way forward, devise a plan of action, and set plans in motion. He has a track record of managing groups by setting targets and gaining commitments through a proven approach to team building gained in a sophisticated manufacturing environment.
Philip has excellent interpersonal skills and the ability to communicate effectively
at all levels. He has the capacity to devise and implement analytical support
programs to drug discovery and manufacturing, based on a thorough
understanding of GMP and GLP and current US and European drug
- Communicates effectively with all levels and disciplines internally and externally
- Works well in a structured team environment being a strong team player in multi-functional organisation.
- Familiar with a wide portfolio of products produced by pharmaceutical companies.
- Enjoys training personnel, preparing lesson plans and visual aids and public speaking.
- Skilled in assessing product performance verses specifications.
- Trained Auditor to ISO 9000 accreditation system
- Safety conscious person; holds certificate from Institute of Occupational Safety and Health (IOSH).
- Well familiarised with US Code of Federal Regulations and UK “Orange Guide”
Philip earned his MSc in Analytical Chemistry at Staffordshire University.
He’s also a member of the Royal Society of Chemistry.
Julie Turner – Regulatory Affairs Consultant – e-CTD submissions
Julie has a broad range of skills including managing internal training programmes, introducing competency testing and a formal regulatory intelligence system.
She also has experience in the preparation and maintenance of marketing authorisation and clinical trial applications in the UK and IE.
- EU, national and international product responsibilities (MA and CT)
- Regulatory EU and global project management
- Preparation of Expert Reports (quality, clinical and non-clinical)
- CTD conversions (Modules 2-5)
- Core Data Sheet preparation
- Regulatory compliance
- Readability testing (performing user tests and preparing associated documentation/reports)
Julie earned her Bachelor of Pharmacy degree (first class honours) from the University of Bradford.
Dr Sean D McCrossen – Regulatory writing and Analytical Sciences Consultant
A chartered chemist with extensive expertise in regulatory writing, pharmaceutical analysis and CMC management. He has in-depth knowledge of pharma, GMP and drug development and skilled in a broad range of CMC activities with specialism in analysis.
Sean has management experience of analytical drug substance projects through R&D preclinical development phase to commercial manufacturing in pharma. He’s a consultant in analytical science supplying CMC support to pharma and allied disciplines.
Regulatory writing, technical authoring and publication
- Reviewed and approved key reports for dossier inclusion ensuring compliance and scientific content
- Constructed responses to over 100 agency questions concerning CMC for IND/ IMPD/NDA/MAA
- Authored reports for Module 3 CTD sections and QOS Module 2.
- Supplied and wrote contributions to End of Phase 2 meetings, briefing documents to international health regulatory authorities.
- Contributed to post approval documentation e.g. EU variations, US Annual Reports – including method updates, stability commitment
- Wrote commercial methods and specifications with attention to batch data, process capability and supplied technical rationale
- Published peer-reviewed articles for scientific journals.
- Author of regular articles, editorial and Q&A pages for electronic publication in specialist chromatography publication and general laboratory magazines
Pharmaceutical analysis expertise and knowledge
- Applied method development/validation expertise (for HPLC, GC, CE, GPC, IC and TLC) to assay, impurities, solvents, metals, genotoxic impurities determinations.
- Solved analytical issues and authored numerous analytical testing methodologies for quality assurance of drug development compounds.
- Led a worldwide company Separation Science Technique Network for 3 years, developed 10/3/1-year plan strategy to integrate chromatography technology developments.
- Led the creation of the first standardised approach to method development across the division. Led implementation of specific HPLC analysis platforms and HPLC method development strategy across global company Chemical Development sites.
- Assessed and presented solutions to complex data sets covering drug substance assay, impurities analysis and stability data. Resolved analysis issues of data treatment for out-of-specification issues, matters of analytical quality and specific separation science technical issues.
Sean earned his PhD in Chemistry at the University of London. He’s also a Chartered Chemist and Fellow of the Royal Society of Chemistry.