Pharmaceutical consultants - meet our team

flexible expertise when you need it

The role of PDS staff is to tell you the current standards for your development regulatory submissions, and what you need to do to meet them. We explain why you need to do what needs to be done, and help you to generate data which will successfully meet the requirements.

Our experienced experts will ensure you receive the best advice and help to get your products to market.

Michael Gamlen - Pharmaceutical Consultant Managing Director and founder of PDS Michael has over 30 years experience of tablet development. He specialises in managing product development, formulation, tablet and process development studies. More about Michael Gamlen
Janet Ellis - Regulatory Affairs Consultant Regulatory Affairs Director Janet has worked in the regulatory consultancy sector for all of her career. She has handled the regulatory affairs of products from the biotechnology, pharmaceutical and complementary therapy. More about Janet Ellis
Paul Cummings - Director of Pharmaceutical Development Paul 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. More about Paul Cummings
Dr Ron Lawrence BSc(Hons), MRSC - Chemistry, Manufacturing and Controls (CMC) Consultant Ron specialises in Chemistry, Manufacturing and Controls (CMC), specifically API and general chemistry support for drug development projects in the biotechnology and pharmaceutical industries. More about Dr Ron Lawrence BSc(Hons), MRSC
Sean McCrossen - Director of Analytical Chemistry A PhD chartered chemist, Sean has extensive expertise in regulatory writing, analytical techniques and chemistry and manufacturing control (CMC) management. More about Sean McCrossen
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. More about Hedley Rees
Jeff Rudolph Jeff is an experienced pharmaceutical scientist with over thirty years in the domestic and international development and management of branded, generic and OTC products. He held senior pharmaceutical. More about Jeff Rudolph
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. More about Brian Matthews
Graham Clapperton - Quality Consultant Associate Director of Quality Graham is an accomplished expert in Quality Management Systems Development and Supply Chain GMP Compliance. He’s held many senior management positions and advised on Quality Management. More about Graham Clapperton
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. More about Paul Butler
Lesley Chaplin - Biologics Specialist Consultant Lesley has extensive experience in the biological field from selection of candidates for development through to supporting phase III clinical trials. Lesley started her own consultancy business in 2007, providing small biotechnology companies with a comprehensive service specialising in purification and scale up of manufacturing processes, analytical expertise and training. More about Lesley Chaplin
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. More about Martin Slade
Susan Macdonald - Regulatory Affairs and Medical Writing With over 25 years experience in the pharmaceutical industry, Susan is a medical writer and regulatory affairs consultant. More about Susan Macdonald

Pharmaceutical consultants - meet our team

flexible expertise when you need it

Michael Gamlen - Pharmaceutical Consultant

Managing Director and founder of PDS

Janet Ellis - Regulatory Affairs Consultant

Regulatory Affairs Director

Paul Cummings - Director of Pharmaceutical Development

Dr Ron Lawrence BSc(Hons), MRSC - Chemistry, Manufacturing and Controls (CMC) Consultant

Sean McCrossen - Director of Analytical Chemistry

Hedley Rees - Supply Chain Management

Jeff Rudolph

Brian Matthews - Medical Devices and Regulatory Affairs Consultant

Graham Clapperton - Quality Consultant

Associate Director of Quality

Paul Butler - Associate Pharmaceutical Consultant

Lesley Chaplin - Biologics Specialist Consultant

Martin Slade - API consultant

Susan Macdonald - Regulatory Affairs and Medical Writing