Dr. Sainkoudje Consulting
Delivering business-centred Regulatory Affairs services & solutions in Europe and around the world
Tyler is a Pharmaceutical Industry expert who served in several global Top-10 pharmaceutical companies, mainly in Regulatory Affairs (RA) as RA Specialist, Manager, and Regulatory Affairs Consultant / Freelancer since 2010. He contributed to development & life cycle management of multiple medicinal products in multidisciplinary teams including R&D, clinical R&D, manufacturing, QC, regulatory affairs, pharmacovigilance, medical/scientific affairs and marketing. He seasoned in all aspects of pharmaceutical regulatory affairs in small & large molecules & in medical devices. He developed realistic, robust regulatory strategies supporting business goals.
He has an extensive hands-on experience in writing & reviewing regulatory documents and a strong track-record of successful regulatory agency interactions & approvals of regulatory submissions (EMA, MHRA, BfArM, ANSM, FDA...), including new product licenses. He is loving, living and breathing pharmaceutical regulatory affairs. Keen to provide regulatory-proof and regulatory-wise contributions to drug development and life cycle management through multifunctional team efforts, aiming to optimally balance patient needs, scientific drug development challenges, regulatory requirements and business opportunities.