Ms. ***** has over 20 years of broad pharmaceutical experience in various areas of clinical and commercial QA/QC, outsourcing, project management and technical CMC-related operations form the basis for the vast knowledge of the regulations and compliance. Prior to forming The ***** Solutions Group, LLC, Emma was Associate Director of QA and then of Process Development/Product Formulation at Sankyo Pharma, Inc. There she was responsible for outsourcing the company’s testing activities, helping facilitate and manage the development and commercialization of company’s drug products and oversaw generation, compilation and coordination of all CMC technical documents required to support US regulatory submissions. Furthermore, for more than 4 years she provided continuous QA/regulatory compliance, technical CMC and strategic input to various project teams with focus on timelines and budgets. Emma also worked in the QA Department at Bristol-Myers Squibb, where she was responsible for ensuring compliance of the internal and domestic vendor operations with relevant good manufacturing practices (cGMP), DEA regulations and corporate policies. Additionally, in the capacity of QA/QC at Jacobus Pharmaceutical, Emma was intimately involved with overseeing and enhancing regulatory (cGXP) compliance of multiple aspects: R&D, manufacturing, testing, packaging, labeling and distribution operations.