Bioneeds India Pvt Ltd

Overview

Bioneeds is an OECD GLP-certified and USFDA audited pre-clinical CRO providing regulatory testing services for Agro chemicals, Industrial chemicals, Pharma, Herbal / Nutraceutical and other industries. Over the past 10 years, Bioneeds has established an enviable track record catering to various segments of the industry with high quality services with stringent timelines.

For Industrial chemicals, Agrochemicals(Plant protection products), Biocides, Flavors and Fragrances we offer Phys-Chem analysis , GLP toxicology studies, Eco-toxicology studies and complete package studies for registration according to CIBRC, EU-REACH, EU-PPP, EPA, PMRA and other global registrations.

Our offerings include,

• Physical chemistry: Water Solubility, Storage Stability under different conditions, Partition Co-efficient, Vapour Pressure, Surface tension, Oxidizing Properties, 5-batch analysis, Analytical tests and Characterization
• Toxicology studies: Acute Six Pack Studies, Skin/Eye Irritation, Skin Sensitization, Mutagenicity, Repeat-dose Sub-acute, Chronic studies, Reproduction toxicity and repeat dose Inhalation studies
• Ecotoxicology Studies: in multiple biotic organisms like Alga, Daphnia, Avian, Fish, Earthworm, Honeybees, Short and long term toxicity studies, Degradation studies
• Synthetic Chemistry: custom synthesis from mg to kg scale, process development - cost reduction processes, novel non infringing processes

Standards & Methodologies

• ICH
• OECD
• EMEA-CHMP
• US-FDA
• SCHEDULE Y
• OPPTS
• CIPAC, ABNT - NBR,
• EC
  
• US OCSPP
  

Qualifications, Certifications, Accreditations & Licenses

• Successfully audited by USFDA with no 483s (January 2017)
• Drug Testing License (DTL) for tests on Drugs /Cosmetics & Raw Materials used in manufacturing for marketing permission 

• ISO 17025 Accreditation (NABL) for Biological, Chemical & Medical device Testing

• AAALAC (Association for Assessment & Accreditation of Laboratory Animal Care International) accredited laboratory for animal care

  Recognized by Department of Scientific and Industrial Research (DSIR) for in-house & Collaborative R&D 

• OECD GLP Certificate by National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Government of India 

• Ministry of Environment, Forests and Climate Change, GOI - Permission to conduct research in animals