Marsha Marande, Ph.D.

Can provide winning global and country specific regulatory strategies both involving submission planning as well as providing guidance and assisting clients’ teams and SME’s for CMC development (meetings, writing, editing) to meet regulatory CMC data needs for new drugs at all stages of development as well as helping supply chain to plan and meet demands.

Unique experience as a scientist (Ph.D. and postdoctoral studies) who started in pharma as an analytical development SME team lead, moved into regulatory and was uniquely exposed to many different types and variations of submissions early in my career which included, drug substance forms, formulations.   All global CMC submissions came through our technical/regulatory group (200 plus a year type volume per individual). Worked at a contract manufacturer (one of two regulatory personnel on site in the plant) and helped build a business from 2 clients to 100 plus.  Reported to the head of quality and was involved in 20 audits/year both client audits and regulatory agency.

Also have unique experience within small pharma companies managing regulatory, quality compliance and manufacturing for multiple projects all a various stage of development at the same time each with their own set of vendors.

Have been involved with leading and managing Teams (comprised of internal members as well as partners and vendors) through complex global submissions, difficult supply issues, formal meetings and interactions with numerous global health authorities (including FDA, EMA, Health Canada & several regional health authorities).  Recent experience includes working on a new IND for a tissue-based combination product and well as combination products that require in depth knowledge in small molecules, biologics, novel excipients and device.

Extensive experience with agency requirements, needs and interactions as well as responses based on stage of development and clinical indication. Have also written/edited and overseen the preparation of regulatory documentation at early stage as well as successful submission of many marketing applications and post approval experience.