Dr Michael Gamlen
Founder and chief executive
Michael is a graduate with first class honours in pharmacy (specialising in pharmaceutical engineering) of Sunderland University and has a PhD from Nottingham University. At Nottingham he trained with professor JM Newton, one of the UK leading tableting researchers and the first person to use tensile fracture stress measurements to evaluate tablets.
Michael spent a year at Beechams Pharmaceuticals working on a completely novel technique to instrument a rotary tablet press. He then joined Wellcome Foundation, where for 14 years Michael was responsible for the development of all tablet formulations including hundreds of clinical trial formulations as well as licensed products (of which six drugs are still on the market). Since then he has formed a consulting business and is founder and chief executive of Medical Device Support Limited.
Andy Micklethwaite
Medical device consultant
Andrew has gained huge experience in medical device manufacturing and regulation through his long career.
He started his working life with Baxter Healthcare, working in product development. His time with Baxter gave him a thorough understanding and appreciation of the benefits of GMP, GDP and a well run QMS.
He then worked at several other international medical device manufacturers before establishing a business focussing on providing contract manufacturing and distribution services for medical devices. This involved supporting a wide range of businesses to ensure they complied with their varied Regulatory requirements. Companies ranged from SMEs to well-known international businesses.
In 2013, Andy moved on to a new role, providing consultancy services to medical device companies. Some of the projects he has worked on during this time include:
- Assisting a PLC company new to medical devices to implement appropriate QMS and leading them through CE marking process
- Leading a start-up company through the process of identification, audit and appointment of both suppliers and distributors to ensure they met the company needs
- Worked with a manufacturing company in a traditional environment to transition work environments, infrastructure and QMS to appropriate levels for medical device manufacturing, including successful implementation of ISO13485 QMS within a tight timescale
- Worked with a medical surgeon who had developed a new CE class IIb device to bring the product to market, including construction of full ISO13485/CE compliant QMS and technical files
Cinzia Boldarino
Regulatory affairs consultant – medical devices
Cinzia has over 20 years experience in the European regulatory environment, 10 of which in medical devices.
Main areas of expertise include definition of strategy, submission and maintenance of technical files, revamping of outdated documentation, gap analysis and due diligence. Experience in classification was gained in a number of case studies.
She deals with notified bodies and competent authorities on applying and maintaining CE marking. She benefits from a huge experience in the pharma sector to give added value when managing medical devices.
She is able to manage contacts with manufacturers, dealing with complaints and recalls, and is well aware of the requirements and obligations about vigilance and surveillance, which she follows on behalf of companies.
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.