PharmaLogic Consulting AB is an independent regulatory affairs consultancy and works with biotech companies across Europe and the USA, focussing on orphan drug products. We provide an individual service to create combined clinical and regulatory plans to support product approval. Our experience and knowledge helps you to navigate the complexities of the regulatory process in a timely and cost-effective manner.
Heather Cook, PhD, MBA – CEO and Senior Regulatory Affairs Advisor
Heather’s formal education includes a Bachelor of Science degree (University of Toronto, 1989), a PhD in Zoology (Neuroscience, University of Toronto, 1995) and a Masters of Business Administration (executive format, Stockholm School of Economics, 2013).
Heather has worked in the pharmaceutical industry for the past 20 years, for both large multi-national, and small biotech companies. While she now specializes in the early development of new medicines, she has experience across the entire drug development process in Regulatory Affairs and Clinical Development. Heather has worked in Canada and several European countries, and havs hands-on experience in global drug development.
While in Canada, Heather worked for the affiliate of a large multi-national company. In the regulatory affairs group, she was responsible for the preparation, submission and negotiation of approval and labelling for a number of new drugs and new clinical indications. Heather subsequently moved to the clinical group where she directed a large cross-functional team who were responsible for the execution of clinical trials, medical-marketing activities and interactions with physicians and academic researchers.
In Europe, Heather has worked in the global regulatory affairs organization of 2 large multi-national companies. In both companies she was responsible for medicines in early development either as a global product team member or as head of department with accountability for the entire portfolio of development products. For the last 6 years, Heather has worked mainly with small biotech companies, focussing on orphan drug products. She has worked with clients to create combined clinical and regulatory plans to support product approval, prepared for regulatory agency meetings. Heather has also prepared and negotiated the approval of orphan drug designation applications for both the EU and US, and in some cases, has helped clients to gather the necessary disease prevalence data to support their successful applications.