CDMO & CMC service Scale-Up and Clinical Trial Material Production Kilo Lab & Pilot Plant Analytical development and regulatory support Laboratoires SYNTH-INNOVE is a small-scale active ingredients manufacturer, batch size range from 0.1 g to 10 kgs. We develop innovative synthetic processes, providing you with tailor-made development and manufacturing of new and complex molecules, as well as all the required analytical and regulatory assistance. Our advantage lies in beating formulation and manufacturing challenges to scale-up production and getting products to market faster. GMP Manufacturing The productions are performed with state-of-the-art equipments, in jacketed reaction vessels located in a dust-controlled zone where the atmosphere is purified by high efficiency (HEPA) filters. Our equipment is compatible with a wide variety of chemicals; reaction vessels and filtration systems are made of inert materials as glass, glass-lined steel, Hastelloy®, Teflon®, Halar.® SYNTH-INNOVE Laboratories facilities are also equipped with pilot scale lyophilization capacities. Critical steps can be performed under class 100 laminar flows. Heat and moisture sensitive chemical substances can be conditionned and freeze-dried in unitary vials. Analytical Development The development of new methods of analysis, their validation, the elaboration of registration dossiers (ASMF, IND, AMM, NDA) The development and validation reports edited by SYNTH-INNOVE meet the ICH guidelines recommendations and satisfies the requirement for a DMF registration. SYNTH-INNOVE Laboratories has more than 12 years’ experience in the constitution of registration files and an excellent expertise in meeting the requirements for European Registration. All APIs Regulatory Documentations submitted to the authorities in Europe or in France by SYNTH-INNOVE laboratories were successfully registered.