3D BioOptima

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 modied resources
• Bioneeds is AAALAC certified for laboratory animal care
• Bioneeds’ in-house R & D unit is recognised by Department of Scientic 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

Aragen is a trusted R&D and manufacturing partner to the global life sciences industry. From concept to commercial, we transform your ideas into solutions for better health.

Whether large pharma or biotech, an agrochemical or animal health company, we provide you global resources and proven capabilities at every stage of the biopharma lifecycle, in small and large molecules. Our ability to offer end-to-end solutions or support standalone programs is underpinned by an innovation mindset, enabling technologies, and a partnership approach to every engagement.

At Aragen, we recognize your work is vital, urgent and impacts lives. Our purpose, ‘In every molecule is the possibility for better health’ motivates us to drive the success of your programs, so that we can together transform hope into health for millions of people around the world.

Eurofins Advinus is your trusted partner for specialized discovery, preclinical and early clinical services. Our facility has 30 years of GLP experience in conducting regulatory studies in compliance with global regulations for supporting clinical trials and registration of substances and products globally.

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 discovery services include comprehensive offerings from Medicinal Chemistry, to in vitro Biology, ADMET and Pharmacology.

We offer end-to-end services for a complete IND/IMPD package that includes Safety Assessment/Toxicology and Drug Metabolism and Pharmacokinetic (DMPK) studies along with Chemistry, Manufacturing and Controls (CMC) services.

DMPK services include full spectrum of in vitro screening services, assay development and validation with customized assays and PK studies. We also provide bioanalytical assay development and validation services in accordance with USFDA and EMA guidelines for both Novel Chemical Entities (NCEs), as well as Novel Biological Entities (NBEs) and Biosimilars.

We have successfully submitted enabled 80+ IND packages for submission to regulatory agencies across the world – including USFDA, MHA and EMA. We offer full range of toxicology services to support NDA filing. We have completed 65+ carcinogenicity studies.

Aragen is a trusted R&D and manufacturing partner to the global life sciences industry. From concept to commercial, we transform your ideas into solutions for better health.

Whether large pharma or biotech, an agrochemical or animal health company, we provide you global resources and proven capabilities at every stage of the biopharma lifecycle, in small and large molecules. Our ability to offer end-to-end solutions or support standalone programs is underpinned by an innovation mindset, enabling technologies, and a partnership approach to every engagement.

At Aragen, we recognize your work is vital, urgent and impacts lives. Our purpose, ‘In every molecule is the possibility for better health’ motivates us to drive the success of your programs, so that we can together transform hope into health for millions of people around the world.

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022) is an integrated contract research, development and manufacturing organization providing scientific services – from early discovery to commercial supply. Our innovative capabilities for novel molecular entities (NMEs) cater to a wide range of industrial sectors, including pharmaceutical, biotechnology, nutrition, animal health, consumer goods and speciality chemical companies.

Our Discovery services include conducting early-stage research from target identification to delivery of drug candidates for further development. Development services encompass activities from pre-clinical to clinical trials including Drug Substance Development (DSP), Drug Product Development (DPD) and associated services to demonstrate safety, tolerability and efficacy of the selected drug candidate.

Our Manufacturing services for small and large molecules include cGMP-compliant facilities for clinical supplies, registration batches as well as commercial volumes through our API manufacturing plant & disposable Biologics manufacturing facility.

Driving our innovative culture is our highly qualified team of 4200 scientists supported by state-of-the-art infrastructure and market-leading technology. Our scientists have both the skills and the capability to deliver great science, ensure robust data management, IP security & quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.

With 2 Mn sq ft of specialist discovery, development & manufacturing facilities, Syngene offers dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife. We also work with biotech companies pursuing leading-edge science as well as multinationals including GSK and Merck KGaA. Smaller and virtual companies, non-profit institutions, academic centers and start-ups also collaborate with us for their research-related requirements.

Write to us at bdc@syngeneintl.com