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Andrew has an engineering doctorate in medical devices and is a talented and versatile consultant who has accumulated over 15 years’ experience in medical device and IVD design and development, regulatory affairs and quality systems, while holding a number of senior positions within a range of companies.
With a PhD in drug development and 10 years of post-doctoral research experience in chemistry and molecular biology, combined with 8 years’ manufacturing and consulting experience in the medical device regulatory and quality arena, Zennia contributes a strong set of regulatory and technical skills to the team.
Elaine has a wealth of experience leading regulatory, quality and clinical operations functions in a full spectrum of companies from small start-ups to multi-nationals within the medical device and wider healthcare industries. She also has over 8 years’ experience working within consultancy with a proven track record in delivering successful projects.
Dipty brings to the team a solid background in regulatory affairs and quality assurance from a variety of medical device manufacturers including a large global corporation. She has particular strengths in the quality assurance field, coming from over 14 years’ experience in the area and is a trained ISO 13485 lead auditor.
Charlotte brings to the team a thorough understanding of both the medical and life sciences fields. Before joining Insight Regulatory, Charlotte had earned several years of regulatory experience working within a joint manufacturing and consultancy company, specialising in the licensing of pharmaceuticals and medical devices.
Meet our team of knowledgeable and experienced experts.
Each member of our team possesses at least one university degree in a relevant scientific discipline and numerous years of professional experience in regulatory affairs and in quality management systems relating to medical devices.