The main changes are as follows: — added informative mapping annexes to relevant regulatory requirements; — clarified terms and definitions used in the document; — expanded the patient groups to include: premature, small child, child, and adolescent; — introduction of inhalation dose; — the threshold of toxicological concern is changed; — expanded the range of volatile organic substances that are tested; — clarified the appropriate breathing gas volumes to be used in testing for VOS; and — clarified the appropriate breathing gas volumes to be used in the analysis.
About us
BIONEEDS INDIA PRIVATE LIMITED is a Bangalore based Contract Research Organization providing Integrated Discovery, Development and Regulatory Services to Pharmaceutical, Biopharmaceutical, Agrochemical, Industrial chemical, Herbal/Nutraceutical and Medical device companies. Accreditation/Certifications • National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Government of India • Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment, Forests and Climate Change, GOI. • State Drug Controller as a Government approved Drug Testing Laboratory for carrying out tests on Drugs / Cosmetics and • Raw Materials used in their manufacture on behalf of licensees for manufacture for sale of drugs / cosmetics • Review Committee on Genetic Manipulation (RCGM), department of biotechnology, GOI to conduct experiments on animals for DNA or Genetically modied resources • Bioneeds is AAALAC certified for laboratory animal care • Bioneeds’ in-house R & D unit is recognised by Department of Scientic and Industrial Research (DSIR) • ISO 17025 certified for Biological evaluation of Medical Devices • Bioneeds has best-in-class infrastructure equipped with state-of-the-art facilities with 2,50,000 sqft built-up area. • Vivarium with 85 exclusive animal rooms built as per international standards • Cutting edge Drug Discovery and Development Labs to support Medicinal chemistry, Biology, In vivo Pharmacology, • Toxicology, Custom synthesis, Process R&D, cGMP manufacturing, Formulation and Analytical development services
- Website
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http://www.bioneeds.in
External link for BIONEEDS INDIA PRIVATE LIMITED
- Industry
- Research Services
- Company size
- 201-500 employees
- Headquarters
- BANGALORE, Karnataka
- Type
- Privately Held
- Founded
- 2006
- Specialties
- Acute and Sub-Acute Toxicity Services, Preclinical Services , Subchronic and Chronic Toxicity Studies, Genotoxicity Studies, Reproduction and Developmental Toxicity Studies, Immunotoxicology Studies, Ecotoxicity Studies, Biological Tests, Bioassays, and Biocompatibility tests
Locations
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Get directions
DEVARAHOSHALLI SOMPURA HOBLI NELAMANGALA
BANGALORE, Karnataka 562111, IN
Employees at BIONEEDS INDIA PRIVATE LIMITED
Updates
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Join us as we embark on an exhilarating journey of innovation and excellence in delivering end-to-end drug development services on a global scale. We cordially invite you to watch and listen to our Group CEO, Dr. Mahesh Bhalgat, as he shares insightful comments on Veeda's recent acquisition of Health Data Specialists (Heads), a Europe-based CRO recognized as a global leader in Oncology Trials. With Heads now part of the Veeda Group, we're well positioned to harness our collective strengths to advance drug development, foster equitable trial access, and accelerate the development of innovative medications that enhance patient care on a global scale. As we move forward, we're excited about the integration and the global reach that the acquisition brings. To know more about this acquisition, write to us at info@veedacr.com or visit https://lnkd.in/dD2XS4cR BIONEEDS INDIA PRIVATE LIMITED Partners in creating a healthier tomorrow. #Veeda #VeedaGroup #HealthDataSpecialists #Heads #Aquisition #CRO #ClinicalResearchOrganization #Bioneeds
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Mahesh Bhalgat appointed by Veeda Clinical Research Limited Research as group CEO To know more about it read our full article here: https://lnkd.in/dR-i_g52 . . #cionews #newsdesk #trendingnews #EvolutionMining #NewLeadership #ChiefTechnicalOfficer #MiningIndustry #TechnicalExpertise #LeadershipAppointment #InnovationInMining #IndustryUpdates #MiningLeaders #CorporateNews #ExecutiveAppointment #TechnicalLeadership #MiningInnovation #ResourceSector #LeadershipChanges
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"Discovery, Development and Regulatory Services" - GLP Certified & AAALAC Accredited Pre-clinical CRO
"Today, on International Women's Day, let's celebrate the achievements, strength, and courage of women around the world. I'm grateful for the incredible women who have paved the way for progress and inspired others to reach for their dreams. Let's continue to work towards a more equal and inclusive world where every woman has the opportunity to thrive and succeed. Happy International Women's Day to all the amazing women making a difference!" #InternationalWomensDay #IWD2024 #WomenEmpowerment #BreakingBarriers #GenderEquality #WomenLeaders #CelebrateWomen #EmpowerWomen #Feminism #WomensRights #EqualityForAll
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"Discovery, Development and Regulatory Services" - GLP Certified & AAALAC Accredited Pre-clinical CRO
If you are attending this prestigious event “EUROTOX 2023” in Slovenia, drop by our Booth #21 to meet our specialized experts of Bioneeds India Private Limited Dr. Nitin Shetty, Chief Technical Officer and Mr. Bopanna, General Manager- Business Development. #eurotox2023 #CRO #preclinicalresearch #toxicology #ecotoxicology #chemistry #drugdiscovery
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