Collaborate anywhere in the R&D Value Chain
- Advinus offers R&D services across discovery, pre-clinical and early clinical development.
- Translational Discovery: From idea to human PoC
- A Best-in-Class molecule engine for a balanced portfolio
- A Target Validation Center to decide on which targets to invest into
- A World Class Drug Development center for cost and time effective pre-clinical development including CMC and regulatory toxicology.
- Support for early clinical development to process development, kilogram scale cGMP capabilities, bioanalytical and sample analysis and NDA enabling regulatory long term non-clinical studies.
- Seasoned team, world class infrastructure and a solid track record.
- Takeda-Advinus Collaboration: Largest discovery collaboration in India on multiple targets and indications, Multiple Clinical Candidates delivered and successfully met all milestones set in the collaboration – collaboration included both novel and validated targets
- Novartis-Advinus Collaboration: Delivered a drug candidate that is now in full development – Phase II
- Merck-Advinus Collaboration: Delivered no go decisions on 2 novel targets (pharmacological proof – target validation )
- J&J-Advinus Collaboration: Delivered validation on 1 target and early decision on a second target
- Celgene-Advinus Collaboration: Novel anti-leishmaniasis leads now directed towards Candidacy
- DNDi-Advinus Collaboration: Collaborated for Drug Discovery and Development of targets for Kala Azar
Advinus Development Facility, Bangalore
Good Laboratory Practice (GLP)
- GLP accredited since 1992 (Germany, Netherlands and India). The first facility in India to attain GLP accreditation. (Through erstwhile Rallis Research Center (RRC), which was acquired by Advinus Therapeutics in 2005)
- Since 2011, India is “Full Adherent” for Mutual Acceptance of Data (MAD) as per OECD. Advinus was the site for inspection for the OECD Mutual Joint Visit with NGCMA. This inspection was instrumental for India’ “Full Adherent” status for MAD.
- Advinus adopts OECD Principles of GLP and conducts studies in compliance with OECD. Advinus data has been successfully submitted to US FDA, US EPA, EMA, MHRA, DCGI and other global regulatory agencies.
GLP Inspections by Monitoring Authorities over the years
- AAALAC accredited since 2001; the first facility in India to receive the AAALAC accreditation.
Central Insecticides Board & Registration Committee (CIB&RC)
- Approved for generation of data in Chemistry; Bio-assay including residue studies, persistence and metabolism; Toxicology and Packaging.
Atomic Energy Regulatory Board (AERB)
- Approval for use of radiolabelled compounds for research
Committee for the Purpose of Control And Supervision of Experiments on Animals (CPCSEA)
- Approval for research for commercial purpose and breeding in-house on small and large animals
Advinus adopts globally recognized quality systems
- Good Laboratory Practice (GLP) for non-clinical studies – accredited since 1992
- Current Good Manufacturing Practice (cGMP) for early clinical supplies
Quality Assurance Unit
Advinus Quality Assurance unit (QAU) consists of highly qualified and experienced professionals. The quality assurance systems and processes include review of documents, conduct of facility-based, process-based and study-based inspections to maintain high standards of quality and monitor studies for compliance to global regulatory requirements.
The QAU reports directly to the Management to ensure that it works independent of the study teams.
- QAU is involved in monitoring studies under GLP and cGMP areas of functioning
- Assure that studies are performed in compliance with the principles of GLP and CMC materials are generated to comply with cGMP requirements
- Inspects and audits facility and processes and assures that studies are conducted in compliance with SOPs and study protocols
- Evaluates and qualifies test sites and contract test facilit for outsourcing any study or study phase
- All SOPs, protocols/study plans, draft and final reports are reviewed by QAU and QAU statements are issued
- QAU is responsible for facilitating inspections/audits by monitoring and regulatory authorities including site visit for auditing by study sponsors.
- Adopting Tata Business Excellence Model (TBEM) in the company
From Lab to Regulatory Submission
- Advinus offers services for integrated Discovery and Product Development.
- We help our clients externalize their R&D by offering one stop shop drug discovery capabilities, from target validation to Candidate selection. We also offer standalone services in to our clients in each of our capability areas.
- Advinus offers end-to-end capabilities for product development and regulatory submission across a wide range of industries, including Pharmaceuticals, Biotechnology, Agrochemicals, Industrial Chemicals (REACH), Nutraceuticals and Medical Devices.
- Regulatory dossier are compiled as per the requirement for submission to US FDA, EMA, MHRA (UK), AEMPS (Spain), Health Canada, TGA (Australia), Medsafe (New Zealand), HAS Singapore and DCGI (India), among others. Advinus is the only company from India that has enabled over 50 IND submissions, multiple NDA enabling long term studies and numerous agrochemical submissions across global regulatory agencies.
- Carcinogenicity studies conducted at Advinus have been submitted to US EPA and in other OECD countries without any reservations.
- Advinus has the ability to compile data in Standard for Exchange of Non-clinical Data (SEND) format also for US FDA submission.