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| CONSULTANCY OFFERED | ||
| Dr. Rowland Burgess and Associates offer a wide consultancy service covering the manufacture, quality control and regulation of human and veterinary pharmaceutical and food industry products. Additional services include advice and training on the implementation of quality systems, microbiological validation and training and the undertaking of Qualified Person duties for pharmaceutical batch release. | ||
| CONSULTANCY SERVICES | ||
| Manufacture and Quality Control * Design and commissioning of manufacturing facilities * Product formulation, development and process validation. * Sourcing and specification of raw materials and packaging. * Preparation of operating procedures and documentation * Advice on quality control including assay design and validation. * Provision of Qualified Person services. * Advice on self-inspection procedures and assistance in self-inspection audits. * Third party auditing of production /testing facilities. * Documentation and implementation of Quality Systems (UKAS, ISO 9000 series) * Microbiological validation of production facilities Regulatory Services * Information and advice on the regulation of pharmaceutical and veterinary products. * Advice on the design and conduct of scientific studies in support of regulatory applications * Preparation and submission of marketing authorisation and manufacturing licence applications * Preparation of Expert Reports in support of marketing authorisation applications. * Liaison with regulatory authorities in respect of licence applications. Training Courses * Provision of in-house and external training courses including Internal Auditor Training Introduction to Microbiology ISO 17025 for UKAS Accredited Laboratories Introduction to Pharmaceutical Good Manufacturing Practice |
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| EXPERIENCE | ||
| Dr. Rowland Burgess has fifteen years experience in a senior scientific
management role for a licensed pharmaceutical manufacturer with overall
responsibility for production, quality control and regulatory functions. Before
entering the pharmaceutical industry he worked for five years on postdoctoral
research in protein chemistry and the teaching of biochemistry/physiology
within UK medical schools. He has been responsible for the design and commissioning of licensed pharmaceutical production units, preparation, documentation and implementation of their operating and quality control systems. Regulatory work has included applications for, review, renewal and variation of product marketing authorisations, EU veterinary mutual recognition and drug residue regulation applications. For five years he has provided consultancy services to the pharmaceutical industry in the above areas including the provision of Qualified Person services. He is a Chartered Chemist and Fellow of the Royal Society of Chemistry, a Member of the Biochemical Society and the British Society for Cell Biology. |
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CAREER |
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| Following two years pre-university period in the pharmaceutical research
and development department of the Radiochemical Centre at Amersham, Dr. Burgess
studied Biochemistry at the University of Newcastle Upon Tyne graduating in
1974. He subsequently obtained a Ph.D. in protein chemistry at Newcastle and
worked for 5 years in postdoctoral protein chemistry research and
biochemistry/physiology teaching in the Medical schools of Nottingham and
Newcastle Upon Tyne Universities. In 1984 he joined pharmaceutical manufacturer Colecton Research Limited as Chief Scientist. He was appointed to the board as Scientific Director in 1989. Between 1994 and 1999 he was permitted by CRL to develop part-time independent consultancy services. Dr. Burgess left CRL in April 1999 to launch RJB Scientific as a full time consultancy. |
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| QUALIFICATIONS | ||
| B.Sc. (Biochemistry), Ph.D., MBIRA, CChem., FRSC | ||
| CONTACT DETAILS | ||
| Dr. Rowland. J. Burgess, R. J. B. Scientific Consultants, 22 The Willows, Highworth, Swindon, Wilts, SN6 7PG. | ||
| Telephone : (+44) (0)1793 763245 Fax : (+44) (0)1793 861112
E_mail : rjbsc@hotmail.co.uk |
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| Alternatively contact us by using The CICA
Enquiry Form Return to CICA Home Page  |
