Brian Back, BSc (Hons), MIQA
Consultant and Auditor
Brian has been involved with pharmaceutical industry for more than 30 years, in a variety of quality-related roles.
He has wide experience in internal and supplier/contract manufacturer auditing, and has acted as liaison for a
number of regulatory audits (by MHRA, FDA, IMB) for various companies in Europe. He also has a background in laboratory
management, both in the UK and Ireland.
Brian has a degree in Pharmaceutical Sciences from the University of Greenwich, and is a member of the Institute of
Quality Assurance. He is a Pharmaceutical Lead Assessor, on the International Register of Certificated Assessors (IRCA),
and was previously a member of the Pharmaceutical Quality Group. Brian is also a member of the International
Pharmaceutical Excipients Council (IPEC).
Contact: brian.back@rephine.com
Peter Balderstone, PHD, C.CHEM, MRSC
Consultant and Auditor
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
Mrs Sue Batten, B.Sc.(Pharm), M.Sc., M.R.Pharm.S., M.C.I.M., M.I.Q.A.
Consultant and Auditor
Sue Batten is a registered pharmacist and an EU ‘Qualified Person’. 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.
Contact: sue.batten@rephine.com
Martin Browne CChem, MRSC
Consultant and Auditor
Martin has over 30 years experience of working for the pharmaceutical industry.
He is a chemist by profession and has been a Qualified Person since 1993.
Having worked for a variety of pharmaceutical companies in process development, Quality
Assurance and production management roles, with involvement in the manufacture and packaging
of most dosage forms, he has a comprehensive understanding of operational, technical and
regulatory matters. In recent years he has worked as a pharmaceutical consultant providing
GMP compliance, operational and facility design advice, and undertaking GMP audits, for a wide
range of dosage form and API manufacturers worldwide.
Contact: martin.browne@rephine.com
Dr Rino Coladangelo MB BS MRCP
Chief Executive Officer
Rino is a physician who trained and worked in London. He has had a particular interest in pharmacology
and held a number of senior management posts in the UK Health Service including Managing Director of a
large Hospital Trust. He has been Chief executive of Medix UK plc, a healthcare research organization,
and has recently taken over as CEO of Rephine Ltd.
Contact: rcc@rephine.com
Rakesh A. Doshi Bcom.(Hons)
Regional Coordinator India
Business Advisor with entrepreneurial background and track record of performing at various
levels of Industry, regarded as change agent successful in attaining improvements in productivity, sales,
profitability, quality, service & safety through planning, quick decision making and tactical execution.
Confident and articulate leader who mixes well with individuals at all organization levels and
builds highly effective team.
As Executive Director & Chief Operating Officer of AMRI India Pvt. Ltd. a wholly owned subsidiary of
AMRI Inc a NASDAQ listed US global provider of scientific services and products to pharmaceutical and biotech
industry, Rakesh had responsibility for 4 manufacturing sites and 200 employees providing Active
Pharmaceutical Ingredients (API) to the pharmaceutical & healthcare industry.
Previoulsy Rakesh co-owned and managed a small scale GMP complaint manufacturing facilities one of
which was a Greenfield site and subsequently expanded by 2 acquisitions. He has hands on experience of
setting up the infrastructure and meeting parameters of production yields and good quality, and also
successful sales and marketing, to European, American and Asian customers.
An accountant by training, Rakesh has also worked in management consultancy and corporate development.
Contact: rakesh.doshi@rephine.com
Robert Haslam BSc CChem MRSC MTOPRA
Consultant and Auditor
Robert has a BSc Joint Honours degree 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.
Contact: robert.haslam@rephine.com
Tony Hughes, BSc (Pharm)
Consultant and Auditor
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.
Contact: tony.hughes@rephine.com
Christopher McLellan PgDip BSc CChem MRSC ACQI
Consultant and Auditor
Chris is a Quality Assurance and specialist having a principle background in QA and Regulatory Governance within API and Pharmaceutical manufacturing sector. He has a
proven track record maintaining a consistent approach to Quality Assurance during periods of significant change, involved in four company acquisitions in the last ten years. He is a chartered member of the Royal Society of Chemistry and holds a Postgraduate Diploma in Pharmaceutical Quality Assurance and a BSc in Applied Chemistry.
He has worked for Searle, Pharmacia and latterly, Pfizer in a variety of roles covering compliance, regulatory affairs and cGMP.
Contact: chris.mclellan@rephine.com
Mukesh Patel, BSc(Hons), CChem, MRSC, CSci, MCIPS
Consultant and Auditor
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.
Contact: mukesh.patel@rephine.com
Mrs Shashi Patel .B.Pharm (Hons) M.R.Pharm.S. QP.
Consultant and Auditor
Shashi Patel is a registered pharmacist and QP. She has expertise across the sphere of pharmaceutical
manufacturing and QA gained from managing an NHS manufacturing unit and QA service as well as many years in
the pharmaceutical industry working overseas in a parenteral manufacturing facility.
She has several years experience in GMP auditing of manufacturing facilities for finished products as well
as API sites and contract laboratories in the UK, Europe as well as India, USA, Israel and Australia.
She also has an interest and has been involved in GMP training at various levels specifically to staff of virtual companies.
Contact: shashi.patel@rephine.com
Matthew Pilsbury, B.Sc. (Hons) ABPI, SDMA
Business Development Manager
Matthew has spent 13 years in the healthcare industry holding various sales, account
management and business development roles within international blue chip
pharmaceutical and medical device companies. Joining Rephine in February 2009,
Matthew's expertise in new business development provides a full time sales
function at our head office in Cambridgeshire.
Contact: matthew.pilsbury@rephine.com
Colin Wood BSc (Hons) CBiol MSB
Consultant and Auditor
Colin has a wide range of experience in pharmaceutical manufacturing and validation.
The majority of his 28 year career has been spent in the manufacture of injectable sterile products including radiological and biological products and the validation of the facilities, utilities and equipment involved in the production, quality testing and distribution of those products.
As manager of a sterile facility he has experience in the preparation of SOPs and manufacturing procedures and the training and management of staff.
He also has experience in the preparation of submissions to and participation in GxP audits by regulatory bodies.
Colin is a member of the following professional bodies: Parenteral Drug Association (PDA), Pharmaceutical and Healthcare Sciences society (PHSS), International Society of Pharmaceutical Engineers (ISPE) and Member of the Society of Biology (MSB).
Contact: colin.wood@rephine.com