Gabrielle Wiederkehr has over 30 years of worldwide regulatory experience in the pharmaceutical industry and has been a consultant since 2013. Before consulting she was leading global regulatory groups at Novartis Pharma, Ciba-Vision, Acino Pharma and Bayer Consumer Care. Her experience includes all product development and life cycle management stages for Rx and OTC pharmaceuticals, generics as well as consumer care products (medical devices, cosmetics, food supplements) in a number of therapeutic areas with focus on GI, ophthalmology, dermatology and analgesics across global regions.
She has comprehensive leadership experience and a solid track record of accomplishing worldwide approvals with proven strength in definition of regulatory strategy, planning and conduct of meetings with worldwide regulatory agencies, generation of briefing documentation, managing preparation of all types of submissions, regulatory intelligence with analysis of regulatory environments/trends including business impact assessment, regulatory project management.
She has a pharmacy degree (MSc Pharm) from the Swiss Federal Institute of Technology (ETH) in Zurich and has excellent interpersonal and communication skills as well as the ability to work in several languages in a multi-cultural context.
Ramachandra (Ram) G. Naik, M.D.
Biostatistics
Regulatory Science & Innovation; Biomedical Advanced R&D
EU Regulatory
Clinical Operations/Project Management
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Health Policy Development
CMC, Formulation/Process Development & Sourcing
Medical Device
Eric Kolb
Melissa Thompson
QA/QC
Medical Writing/Electronic Submissions
Kristi Hultberg, B.S.
Botanicals
Government Relations and Public Affairs
Defense & National Security Practice
Commercialization and Business & Corporate Strategy
Kinexum Associates
Elijah Abass