Eurofins Advinus is a premier contract research, development and manufacturing organization (CRDMO) serving diverse industries to help advance their R&D programs within defined timelines with highest level of quality. With over 30 years of GLP experience we have a proven track record of successfully delivering many integrated and stand-alone projects to meet our partner’s requirements. Our drug di
scovery services include medicinal and synthetic chemistry, ADMET/DMPK and Discovery Biology across various therapeutic areas. We have over a decade of drug discovery experience for novel, first-in-class targets as well as fast follow on targets and have produced multiple assets that are in preclinical and clinical development. Our preclinical development services include process development, DMPK and safety assessment for developing full CMC & Pharmtox packages towards IND submissions. We provide bioanalytical assay development and validation services in accordance with USFDA and EMA guidelines for Novel Chemical Entities (NCEs), Novel Biological Entities (NBEs) and Biosimilars. In addition to preclinical studies we offer biocompatibility testing services for medical devices. Eurofins Advinus supports drug substance requirements from multi kilogram to multi-ton scale for preclinical toxicology studies, clinical trials and commercial manufacturing. We manufacture RSMs, advanced-intermediates, APIs and NCEs. We provide seamless transition from candidate selection to commercialization. Our scientists and process engineers have excellent experience in developing new, safe and efficient route for complex molecules. Our scientific team is well versed with spike/purge studies, impurity identification, in silico analysis to assess Potential Genotoxic Impurities (PGIs) and developing analytical methods to quantity, process safety studies, polymorph and salt screening and QbD based process development for late phase compounds. For the Agrochemical sector, Eurofins Advinus offers product development services to support global regulatory submissions. We have successfully executed studies following all international guidelines - OECD, US-EPA, CIPAC, EEC, FAO, ABNT, NBR, JMAFF, SANCO, ICH, etc. We offers a wide range of field and lab trials to the manufacturers of Agricultural inputs, like pesticides, biopesticides, fertilizers, plant nutrients, bio-stimulants, plant Growth promoters / regulators, etc. We are your ideal partner for safety testing and risk assessment.
