Sandeep P. Modi, PhD, is experienced in ICH guidelines and developing CMC regulatory strategies for global applications (IND/CTA/NDA/MAA), and is successful in the timely preparation of CMC documents for global regulatory submissions that address development and manufacturing needs and result in favorable health authority reviews. Mr. Modi is skilled in leading meetings, setting priorities, and negotiating resolution for timelines, technical and regulatory issues with internal functions, external partners, health authorities, and international CROs/CDMOs, and has represented pharmaceutical development on due diligence teams for in-licensing of new chemical entities and out-licensing of internal products. Sandeep also has project planning and management experience in managing an extensive portfolio of small molecule candidates through CMC development.
Posted in Who’s Who at EAS.