Chemistry, Manufacturingand Controls (CMC) for US & EU Our services We guide you from product development strategy to market authorisation Product development: Supporting the development of the best product while ensuringquality compliance - Strategic consultancy during global pharmaceutical development and lifecycle management Exertise in all types of API (chemical, biological, herbals) – Development of ASMF, DMF, CEP – Development of USP/EP monographs - Drug product development: - Formulation (development, patentability), process (scale-up, validation, manufacturing strategy) - Analytical development (development, validations and transfer, gap analysis, specifications) - Stability studies (design, trend analysis, setting of shelf life) - Project management: coordination of all activities in pharmaceutical development from API selection, product development, clinical supplies, transfer to CMO, to registration and geographical roll out, including CMOs andThe team CROs management CMC Regulatory support: Interacting with authorities at every stage of developmentA team of experts, project managers and and generating associated CMC documentionta scientific writers with significant experience - Scientific writing of regulatory documents: ASMF, DMF, CEP, IND, IMPD, MAA and NDA / BLA module 3, writing of responses to agency questions. in the pharmaceutical industry. - CMC regulatory strategy and meetings with health authorities - Geographical roll out Our clients Decision making to drive investments: Due diligence, gap analysis and experts reviews From start-ups to global pharma companies Maintenance of products on market: Post MAA/ lifecycle management with CMC with punctual, repetitive or permanent need variations for support. When work with us? Why work with us? The team can cover any step of the product development process, registration as well as product maintenance activities, providing consultancy or hands-on Our CMC team members have a flexible operational support. skill set ranging from product development Among our latest missions strategy to operational execution, as well as leading and managing projects. They • Writing CMC modules for submission in US and EU are available to support you through the • Strategic advice on the CMC data positionning in CTD modules development of drugs, biologics, ATMP, • Subject matter expert for impurities and other analytical activities medical devices and consumer health care • Writing Product Quality Reviews products. • Response strategy to health authorities