Dr. Radhika Ramachandran,
Head of Medical Regulatory Writing
Freyr Inc.
Dr. Radhika Ramachandran is a distinguished expert in the field of biotechnology and medical writing, bringing over a decade of experience across diverse industries including research and development, clinical research, teaching, and regulatory medical writing. Holding an M.Phil. and a Doctorate in Biotechnology with a specialization in Myco-remediation and Cancer Biology, where her groundbreaking work focuses on the development of anticancer and antimicrobial drugs derived from marine microorganisms using natural products. Dr. Radhika’s academic background is complemented by multiple certifications and degrees, including an MBA, a PG Diploma in Clinical Research. Currently, she is focusing on research in artificial intelligence (AI), expanding her expertise to integrate cutting-edge technology into the field of biotechnology and regulatory affairs/medical writing. As a Certified Medical Writer and a seasoned trainer, Dr. Radhika has a profound expertise in regulatory medical writing and review. She currently serves as the Senior Manager and Head of Regulatory Medical Writing at Freyr Inc., leading and managing a dynamic team of over 35+ regulatory medical writing professionals dedicated to providing comprehensive regulatory services for medical devices and in vitro diagnostics (IVDs). Her extensive experience spans the development of over 1000+ regulatory medical writing documents, covering clinical trial documentation and the creation and review of various critical reports for medical devices (MD) and in vitro diagnostic devices (IVDs). She is well-versed in EU MDR and EU IVDR compliance and has authored and reviewed a wide range of documents, ensuring they meet global regulatory standards. Beyond her role at Freyr Inc., Dr. Radhika is a prolific author and reviewer for both national and international journals, furthering the impact of her work in the scientific community. Additionally, she holds membership in esteemed associations such as the European Medical Writers Association, Marine Biological Association of India, Indian Science Congress Association, Regulatory Affairs Professional Society, and American Medical Writers Association. For a detailed overview of her research and publications, please visit her profiles on Google Scholar, ResearchGate, and LinkedIn.
