Our vision as a medical device consultancy is to help manufacturers and distributors to navigate the increasingly complex world of regulatory affairs. We specialise in intelligent regulatory strategy and delivery for our medical device and IVD partners.
At Insight Regulatory Consulting Ltd we partner with businesses to navigate regulatory and quality system requirements in line with your goals. This is founded on our depth of experience and the expertise that we have built up working in SMEs and in multinational corporations. We realise the value of speed-to-market, avoiding unpleasant surprises along the way. We are a small team of PhD-level scientists, able to appreciate the scientific basis of developments and to engage with regulatory bodies with credibility. We are also specialist IVD regulatory consultants.
When you contact us, you will be talking direct to the principals - as a small consulting firm we prefer to deal direct with our clients, without a “gatekeeper”, to build up a thorough understanding of your needs and expectations. This contributes to ensuring that our help is focussed on the areas that you need and that will add the greatest benefit. We have worked this way since 2019, helping a wide range companies of all sizes and specialities.
Each member of our team has PhD-level research experience in medical fields, as well as numerous years of professional experience in regulatory affairs and in quality management systems relating to medical devices.
Andrew is the Managing Director and founder of Insight Regulatory Consulting. Before setting up Insight Regulatory in 2019 Andrew had several years as regulatory manager and head of RA in MedTech manufacturers, going on to be technical director at a regulatory consulting agency. His scientific pedigree includes a Masters by research in biomolecular science and an Engineering Doctorate in Medical Devices from the University of Strathclyde.
Zennia is our senior regulatory and quality consultant. Zennia followed her PhD in drug development with 10 years’ post-doctoral research experience in chemistry and molecular biology, building expertise in a wide range of analytical methodologies. She then moved into medical device manufacturing industry in a regulatory capacity before further expanding her expertise with 8 years’ consulting experience in the medical device regulatory and quality arena, Zennia contributes a strong set of regulatory and technical skills to the team.
I cannot overemphasise the importance and value Andrew and the Insight team have provided to our company. Ocupeye has collaborated with key persons covering diverse disciplines to bring our medical device to market. Regulatory as part of the business jigsaw is complex and requires a thoroughly professional/reliable approach. We additionally needed pro-active leadership and an understanding and commitment to deadlines. Insight have delivered on all fronts and it is with pleasure I recommend Andrew’s company.
