We are a GLP-certified and AAALAC accredited pre-clinical CRO providing regulatory testing services for Pharmaceutical, Biopharmaceuticals, Agro Chemicals, Industrial Chemicals , Medical Devices, Herbals and Nutraceuticals . Our GLP certification is endorsed by BfR Germany too. On the Pharma side we offer GLP toxicology studies in compliance with OECD, FDA, EU, DCGI Schedule Y and RCGM guidelines from our state-of-the-art facility at Bangalore. Over the past 7 years, Bioneeds has established an enviable track record catering to the pharma / biotech / agro / chemical industries with timely and cost effective services. Over 3400 GLP studies have been successfully delivered from Bioneeds.
Some key highlights about our integrated Regulatory development centre are,
GLP Toxicity studies: Acute Studies - Oral, Dermal, Eye, Inhalation, Repeat-dose sub-acute, sub-chronic and chronic studies, Reproductive Tox screening studies, Genotoxicity Studies and Safety pharmacology studies
IND & NDA enabling toxicity studies with toxicokinetic assessments
Bridging studies and consulting for 505 B (2) strategies
Impurity Qualification studies, PK Studies in rats
Chemistry: Custom synthesis of a wide variety of organic compounds from mg to kg scale, Process development, route scouting and Impurity profiling Our engagement models are flexible and we work on project based or on Fee-For-Service based or models as per the convenience of our clients.
For Agrochemicals, Pesticides & Industrial Chemicals we offer GLP toxicology studies, Eco-toxicology studies, Phys-Chem analysis and Packaging Solutions for registration of agrochemicals and household pesticides according to OECD, CIPAC, OPPTS, SANCO, EC, EPA and CIBRC guidelines. GLP Toxicology studies: we do Acute Toxicity Studies - Oral, Dermal, Eye, Inhalation, Repeat-dose sub-acute, sub-chronic and chronic studies, Reproductive Tox screening studies, Genotoxicity Studies. ·Physical chemistry: we do 5-batch analysis, Analytical Testing, Characterization as per OECD.Ecotoxicology Studies: we do as per OECD Guidelines in multiple biotic organisms like Alga, Daphnia, Avian, Fish, Earthworm, Honeybees Chemistry: We undertake custom synthesis from mg to kilogram scale, process development, cost reduction processes, novel non infringing processes.
For Medical Device testing, we offer ISO 10993 testing services offered by us include Cytoxicity and Genotoxicity, Systemic Toxicity, Sensitization and Irritation, Hemo-compatibility and Implantation testing. We also offer tests under USP Plastics (USP I-IV).