Linda Rawlings

Linda is Principal Regulatory Consultant and a Director of empatec ltd which was established in March 2003. She is an experienced regulatory professional with a sound technical background and specialist knowledge of pharmaceutical and biotech regulatory affairs and product development strategies. Linda is currently working with blue chip and early stage companies on various aspects of dossier preparation and provision of regulatory consulting advice.

Linda began her career with Smith & Nephew Research as project leader and Head of Microbiology, she moved into regulatory affairs initially with Fison's, followed by Schering Plough and then worked as an independent regulatory consultant, gaining experience across a number of therapeutic areas and product types including inhalation products, oral anti - infectives, biological implants and over-the-counter medicines including legal category changes. She has spent time at the University of York facilitating research collaborations with regional SMEs, and commercialising bioscience as General Manager of Bioincubator York Ltd. Linda held board positions with two oncology - based University spin-out companies.

From July 2004 to March 2006 Linda also spent part of her time as Programme Manager of the Yorkshire Forward-funded Specialist Bioscience Advisory Service which provided advice to bioscience SME's across the Yorkshire and Humber region through business consultants Deloitte and law firm Eversheds.

Linda is a registered member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and has previously been a member of their biotechnology committee. She is also a strong supporter of the regional bioscience cluster and has spoken at the White Rose Bioscience Forum in 2003 and 2005, and delivered the session on regulatory affairs for the innovative Bio2Work programme for new graduates run by the South Yorkshire Bioscience Enterprise Network in 2005.

Aileen Quinlan

Aileen joined empatec ltd in September 2007 as a Regulatory Affairs Associate. She is an experienced industrial microbiologist and quality assurance professional, and is now looking forward to applying relevant experience in the development of a future career in the regulatory profession.

Aileen also began her career at Smith & Nephew Research, originally working with Linda in the Microbiology Laboratory and later becoming the Head of Microbiology. After 5 years experience as a microbiologist and manager in a research/GLP environment, she moved into quality assurance, as Quality Assurance Manager at the new Smith & Nephew Research Centre in York. This move allowed her to gain experience with the management and audit of ISO 9000 and GLP quality systems. She was also involved with the application of GMP principles to the manufacture and release of clinical trial materials at the research centre.

Aileen's particular interest in GMP led her to undertake QP training and ultimately another career move to take up the role of QA Microbiology Manager at the Smith & Nephew Wound Management manufacturing site. In this role she gained experience in the broader application of GMP and EN46000 to the manufacture of medicines and medical devices respectively. She has particular expertise in the microbiological aspects of sterile product manufacture, environmental monitoring of cleanrooms and operation/validation of sterilization processes (steam, gamma irradiation and ethylene oxide).

During her 18 years with Smith & Nephew she has been a member of BARQA, the Institute of Biology, the UK Panel of Gamma Irradiation Microbiology Group and the ABHI Microbiology Group. Her educational qualifications include BSc and PhD in Microbiology and a Postgraduate Diploma in Pharmaceutical Quality and GMP. Her audit qualifications include Lead Assessor and Auditing Sterilization of Medical Devices.