Pharmaceutical Development Services experts

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

• Expert in outsourcing all aspects of product development.
• Rare 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 PhD at
Nottingham University.

Janet Ellis
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 industries including vaccines, novel dosage forms, generics, OTC products, herbal and homeopathic medicines, food supplements and
borderline products.

She has project managed a wide range of submissions including EU mutual recognition, centralised and national marketing authorisation applications, clinical trial applications and submissions to Ethics Committees and has also handled applications to regulatory authorities in Europe, The Middle and Far East, South America,
Asia and Australasia.

She has a special interest in borderline substances and can provide advice on the advertising and promotion of products, including the preparation of labels and leaflets.

Janet has a background as a pharmacist, with a PhD in pharmaceutical microbiology from the University of Nottingham.

Eve Roodhouse
Regulatory Affairs and Technical Adviser

Eve joined PDS in 2007 as a Regulatory Affairs and Technical Adviser with valuable experience in many areas of drug development.

She has worked for a large Pharma company for most of her career, in various roles from analytical chemist and development scientist (providing product development project management), to senior technologist in the operations and supply chain group, where she provided technical and management support for technology transfers, change control coordination and process development
with third party contractors.

In her current role at PDS she has undertaken a contract in the regulatory group of another large Pharma company, preparing variation applications for changes to the SmPC and PIL and for quality changes to a haematology product. In addition to this, she has prepared chemistry/pharmacy modules of Marketing Authorisation applications for submission in the EU, prepared clinical overview and summaries of a well established medicine, compiled Ethics Committee applications and performed regulatory due diligence.

Eve graduated from Greenwich University with an honours degree
in Chemistry.

PDS ASSOCIATES

Brian Matthews (coming soon)

Hedley Rees

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 Bioindustry Association's Manufacturing Advisory Committee and has previously lectured strategic supply chain management for the CIPS professional stage examinations.

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 development positions at McNeil Laboratories (J&J) and spent 23 years at AstraZeneca Pharmaceuticals or its predecessor companies where his responsibilities included V.P., International Pharmaceutical Development/R&D Operations. Recently, Dr. Rudolph has provided consulting services to the healthcare industry in the areas of CMC, process optimization, production troubleshooting, device design, organizational and business development as well as serving as an expert witness on formulation/drug delivery patent cases.

Ron Scott
Expert, Pharma and Chemical services

Ron has been highly successful at identifying low cost sources of chemicals and synthetic intermediates of high quality, and managing chemical synthetic development. He will expertly manage your custom synthesis for you, identifying and managing contractors with the skills to meet your product's requirement. These might include containment, volume, or complexity. He has extensive experience of the development of highly potent compounds.

His expertise includes safebridge certification, auditing preparation, continuous improvement of synthetic chemical processes, major change programs, mergers and acquisitions, inward/outward technology transfer, new product registration, and commercial manufacture of pharmaceutical chemicals.

Ron has over 24 years experience in pharmaceutical research, development, manufacturing and new business start-up in the global pharmaceutical, biotech and healthcare industries.

He's had extensive experience of compliance with health, safety, environment and quality regulations.

Ron graduated with an award winning first class honours BSc in chemistry from The Queen's University, Belfast and subsequently a PhD in synthetic organic chemistry under the supervision of Professor R Grigg FRS also at The Queen's University, Belfast.

Meet our team of experts

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