The Team |
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Iain Mathieson BA (Hons) -
Commercial Director
Iain has extensive, strategic and operational, experience in sales and marketing. He has managed orgainsational change nationally at senior level across technical, purchasing, training, and development, and health and safety functions. Iain has a broad business background gained through blue chip FMCGs and the financial services sector. Contact: iain.mathieson@rephine.com Tel: +44 (0) 1763 853135 Fax: +44 (0) 1763 853573 Martin Slade, D.Phil. C.Chem MRSC - Technical Director Martin is a chemist and has worked for many years within the generic pharmaceutical industry. In addition to academic qualifications, Martin is an associate member of the Institute of Chemical Engineer and a member of the International Society for Pharmaceutical Engineering. Martin has 25 years experience in API process development and scale-up to GMP requirements, and the design and construction of plants to make APIs. He has travelled extensively and visited many API factories world-wide including India and China. He is experienced in GMP auditing, particularly API plants to Q7A guidelines and is a QMS 2000 auditor registered with IRCA. Contact: martin.slade@rephine.com Tel: +44 (0) 1763 853135 Fax: +44 (0) 1763 853573 Peter Balderstone, PHD, C.CHEM, MRSC - Senior Pharmaceutical Consultant Peter is a trained ISO9000/PS9000 Senior Pharmaceutical Consultant and has had many years experience in the international pharmaceutical industry. He has operated in the manufacturing and pharmaceutical development sector, specialising in the management of stability testing, the selection, evaluation and auditing of contract partners, and in the qualification and validation of laboratory instruments and computerised systems. Contact: peter.balderstone@rephine.com Tel: +44 (0) 1763 853135 Fax: +44 (0) 1763 853573 Tony Hughes Tony Hughes has a wide range of experience in the field of pharmaceutical processing, special purpose machinery design, facility design and start-up projects; he is an industrial pharmacist of 20 years experience and a Qualified Person. During his career in the pharmaceutical industry he gained wide experience in all aspects of pharmaceutical manufacture. He has been employed in the field of pharmaceutical consultancy since 1995 and during that period worked with two of the UK's leading pharmaceutical consultancy companies. As a consultant he has been involved with many of the major pharmaceutical companies in Europe and the United States advising on a variety of activities including process definition, equipment specification, procurement, validation and site master planning and rationalization. Tel: +44 (0) 1763 853135 Fax: +44 (0) 1763 853573 Mukesh Patel, BSc(Hons), CChem, MRSC, CSci, MCIPS Mukesh has a unique blend of both technical and commercial experience and qualification. After graduating in Chemistry from the University of Leeds, he pursued a career in industry with concurrent research papers published in the field of organophosphorus chemistry. Mukesh is eligible to act as a Qualified Person under the permanent provisions of directive 2001/83EC. During his career, he has held posts in the fields of R&D, Procurement, Regulatory Affairs and senior management roles in Quality Assurance and Pharmaceutical Compliance. As well being a chartered chemist and chartered buyer he is also a Dale Carnegie Management graduate. Mukesh has conducted both QA and commercial due diligence audits on an international basis and is an ISO lead auditor. Audits cover API (ICHQ7) to various GXP, specializing in pharmaceutical print origination. Tel: +44 (0) 1763 853135 Fax: +44 (0) 1763 853573 Mrs Sue Batten, B.Sc.(Pharm), M.Sc., M.R.Pharm.S., M.C.I.M., M.I.Q.A. Sue Batten is a registered pharmacist and QP. She has expertise across the sphere of pharmaceutical QA gained from managing an NHS regional QC laboratory and QA service as well as many years in the pharmaceutical industry, including project management of clean room building and validation. She is a qualified Lead Auditor, experienced in GMP auditing of manufacturing facilities, clean room services and contract laboratories. A pragmatic approach to documentation helps remove unnecessary duplication, improving efficiency whilst keeping within regulatory requirements. Tel: +44 (0) 1763 853135 Fax: +44 (0) 1763 853573 Robert Haslam BSc CChem MRSC MTOPRA Robert has a BSc (Joint Honours ? Chemistry and Physics) from the University of London, and is a Chartered Member of the Royal Society of Chemistry. Robert is an EU "Qualified Person" for release of investigational and marketed products, and has over thirty years experience of pharmaceutical development, API and dosage form manufacturing, validation, commissioning, QA and regulatory affairs. He regularly advises companies worldwide on requirements to achieve EU and FDA GMP compliance. From 1995 through 2001, he was Technical Director for Shire Pharmaceuticals during its growth from a start-up, through IPO to become a multinational company. From 1991 through 1995, Robert was Technical Director for Imperial Pharmaceutical Services Ltd, before its merger with Shire. Prior to his work with Imperial and Shire, he held a range of technical management posts with Rorer Health Care, May & Baker and Roche. Tel: +44 (0) 1763 853135 Fax: +44 (0) 1763 853573 Rephine Lower Gatley Steeple Morden Hertfordshire SG8 0NR United Kingdon |
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