Ramsharan Singh

Consultant, Cmc @Multiple Companies

Manage clinical supply chain for clinical labeling, packaging, storage, distribution, returns and destruction from preclinical to all phases of clinical studies including Phase 1 to 4. • Manage over-encapsulation (OE) campaigns to provide comparator products for clinical studies. • Select, manage and negotiate with clinical supply packaging and distribution vendors for high quality and cost-effective contracts in compliance with cGMP and other regulatory requirements. • Review clinical packaging master batch records, executed batch records, labeling materials and other documents required to ensure regulatory compliance and to meet clinical study protocol requirements. • Manage clinical supply at external depots and with IWRS vendors for clinical supply chain. • Experience in global management of clinical supply, procurement, shipment and packaging to ensure local regulatory requirements. • Provide guidance to clients on all sections of CMC documents for regulatory filings such as IND, IMPD, CTA, NDA (505(b)(1) and 505(b)(2)), ANDA, BLA, MAA, DMF and sNDA/PAS etc. and PAI readiness with FDA, EMA and Health Canada for investigational and new drug product applications in eCTD format. • Review all sections of CMC documentations during due diligence for in-licensing new products and for partnership negotiations. • Review manufacturing master batch records, executed batch records, protocols, methods, technical reports, presentations and regulatory submission documents and to provide guidance on all CMC activities to ensure regulatory compliance for regulatory submissions. • Provide guidance on various oral product manufacturing unit operations for tablet and capsule drug product manufacturing processes such as wet and dry blending, granulation, roller compaction, hot melt extrusion, milling, tableting and film coating etc.