Sharifa Maskati, M.Sc., Senior Manager, Regulatory Affairs, Pharmaceuticals & Healthcare

Sharifa Maskati has 18 years of experience working in global pharmaceutical Regulatory Affairs. As part of a team for various international pharma companies, she has been involved in preparation of various submissions from NDS, ANDAs, ANDS products in Canada, US and globally in the eCTD format. She is well versed in the CMC requirements for different types of products, and advises and helps clients in preparation of the CMC dossier.

Sharifa has worked extensively on Clinical Trials Applications (CTAs) for Canada and INDs for US for various products pharmaceuticals & biologics, and she provides strategic regulatory guidance for CTA submissions to clients. She has invaluable experience in dealing with Health Canada and FDA, and acts as liaison for the clients to facilitate meetings, provides responses to information requests, and offers any guidance that they need for approval of their product with the Health Agency.

Sharifa also has experience working with wide variety of products from NHPs, cosmetics, and most recently psilocybin (filed a CTA for psilocybin in Canada). Her knowledge and experience on the quality side with Drug Establishment licenses (DELs) in Canada is also very beneficial from the product development and regulatory perspective.

In her current role as a Senior Manager of Regulatory Affairs, Sharifa manages a wide variety of projects for clients (i.e., CTAs, CTA-A, CTA-Notifications, DIN & post DIN changes, INDs & maintenance, DMFs for Canada, US and CEPs for EU, and registering disinfectant products in Canada).