Femi Morakinyo
Dr. Femi is a seasoned scientist and regulatory affairs expert with a rich background in guiding medical product development processes from conception to market authorization, ensuring compliance with stringent Health Canada and FDA standards. With extensive experience spanning both academic and industry settings, Femi has seamlessly transitioned from conducting cutting-edge research as a scientist to providing invaluable regulatory guidance and support as a regulatory expert.
In his current role, Femi specializes in crafting comprehensive regulatory strategies and meticulously preparing applications for a diverse range of products, including supplements, natural health products, pharmaceuticals, and medical devices. He excels in guiding companies through complex regulatory pathways, ensuring compliance with stringent requirements. His proficiency extends to product category feasibility assessment, regulatory pathway optimization, and strategic planning, leading to successful submissions to the regulatory authorities.
Femi actively supports sponsors in adhering to good clinical practices, conducting well-designed clinical trials, and achieving the goals of the trial. A collaborative professional, Femi aligns regulatory strategy with business priorities. His commitment to excellence ensures robust compliance across board. Femi is an active member of the Regulatory Affairs Professional Society. His deep knowledge and unwavering passion for regulatory excellence drive meaningful contributions to the dynamic biotechnology landscape.