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Description

Eurofins Advinus Private Limited 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 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. We offer a complete suite of drug discovery and development services. Our drug discovery services include medicinal and synthetic chemistry, ADMET/DMPK and Discovery Biology across various therapeutic areas. Our preclinical development services include process development, DMPK and safety assessment for developing full CMC & Pharmtox packages towards IND submissions. Our team has immense experience with NDA-enabling studies. Data from our labs has been successfully submitted and approved by various regulatory authorities. We have a track record of 90+ INDs, 65+ carcinogenicity studies, 25,000+ regulatory studies. We offer biocompatibility testing services for medical devices. We have in-house expertise for bioanalytical assay development and validation services in accordance with USFDA and EMA guidelines for Novel Chemical Entities (NCEs), Novel Biological Entities (NBEs) and Biosimilars. We support 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. In the last 5 years, we have completed 100+GMP campaigns. For the Agrochemical sector, we offer product development services to support global regulatory submissions. We have successfully executed studies following all international guidelines. We offer a wide range of field and lab trials to the manufacturers of Agricultural inputs, like pesticides, biopesticides, and fertilizer.