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About KIMIAC

Kimiac provides leadership for developing healthcare products to start-ups and biotech companies. Based on the 25-year expertise of Dr. Karine BERTRAND, it specializes in the development of the product itself, i.e., CMC ("Chemistry, Manufacturing and Controls"), the 3rd pillar of drug development, alongside non-clinical and clinical developments. Kimiac is able to devise sound, scientifically based CMC strategies to help companies secure their developments from the earliest stages of discovery through to commercialization. More specifically, Kimiac provides its clients with scientific and technical support in the field of CMC through - the upstream definition of a CMC development plan, scientifically relevant, efficient and that meets regulatory requirements, - the management of the defined action plan throughout the project to guarantee its proper execution, - the design of CMC-related experimental studies, the analysis of results, the validation of technical and scientific quality of deliverables and their documentation, and integration in regulatory brochures: * Medicinal chemistry, design, and identification of lead compounds, NCE (New Chemical Entities) chemistry; * Pharmaceutical development of new drug products, formulation, QBD (Quality-By-Design) process development, optimization and scale-up through to industrial scale, manufacturing of clinical batches; * Analytical development, aQBD (analytical QBD), method validation and quality control; Kimiac selects service providers capable of carrying out the studies defined in the development plan to the required standard, and manages them throughout the duration of the studies. Kimiac also handles the drafting of regulatory documents (IMPD, IND, etc.) and their defense before the health authorities as required (Pre-IND meetings, Scientific Advice, EoP2 meeting, etc.); likewise, it can contribute to drafting of papers, patents, etc.

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