DRIVING REGULATORY APPROVALS &
RESULTS
 

We are a consulting firm for the pharmaceutical regulatory process with drug approvals and unparalleled breadth and depth of knowledge pertaining to the US and European regulatory frameworks. We can work with you to accomplish your business objectives and ensure regulatory compliance

 

Myleen is an experienced Regulatory Professional in drug product development, marketing registration, and pre- and post-marketing maintenance: IND/CTA, Drug Master Files, Orphan Applications, Scientific Advice, Marketing Authorization Applications, as well as Supplements, Amendments, Annual Reports/Notifications, Variations, and Renewals. 26 years of experience in the research and development of drugs and biologics (11 years in rare disease) with 20+ years in Regulatory, in the areas of Metabolism and Endocrinology, Gastroenterology, Neurology, Dermatology, and Cardiovascular. Direct Regulatory experience in leading, overseeing, and/or contributing to the filing of 4 NDAs, 2 BLAs, 5 MAAs, 2 NDSs, as well as 16 INDs, and 13 CTAs. Results-oriented, multi-tasking, and effective in submissions and regulatory authority interactions in US, Canada, EU, and Rest of World (ROW). Regulatory Affairs Certified (RAC) - US and EU.