Pharmaceutical product development
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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.

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Dr 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.

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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.

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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.

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Dr Ron Lawrence

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.

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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.

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Hedley Rees

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.

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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.

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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.

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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.

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