Eurofins Advinus Ltd (formerly Advinus Therapeutics Limited) is a premier R&D services company that supports the discovery and development of compounds for diverse industries including Pharmaceuticals, Biologicals, Nutraceuticals, Cosmetics, Medical Device, Specialty Chemicals and Agrochemicals.
Our facility has over 25 years of GLP experience in conducting regulatory studies in compliance with global regulations for supporting clinical trials and registration of substances and products globally. Eurofins Advinus has been inspected twice by the USFDA for GLP studies submitted as part of IND packages. We have submitted 50+ complete IND packages globally. We have also conducted over 60 carcinogenicity studies and ~10,000 regulatory and non-regulatory studies for our global clients.
Our Drug Discovery services include – Discovery chemistry ( Medicinal Chemistry / Synthetic Chemistry / Analytical Chemistry), Discovery Biology ( In Vitro Biology /In Vivo Pharmacology), DMPK/ADMET( In Vitro ADME Assays / In Vivo PK Studies / Discovery Bioanalysis)
We offer end-to-end services in the areas of preclinical toxicology testing, chemical process development, analytical R&D, drug metabolism and pharmacokinetics for IND submission. In addition, the company also offers long term non-clinical toxicology testing, including carcinogenicity studies, in support of pharmaceutical new drug applications (NDA).
We offer comprehensive services to support Agrosciences industry since 1992. These include Phys-chem, Residue, 5 batch, E-Fate and Regulatory Toxicology services to enable registration of its clients’ products globally. The studies are conducted in accordance with regulatory requirements of OECD, USEPA, EMA, ICH, JMAFF, ASTM, Brazilian, Indian CIB and other global guidelines.
Mini hERG (hERG screening)
Dose range finding studies
Screening CVS function in telemetered dogs
Medical Devices Testing (ISO 17025 & GLP)
We offer full scope of testing as per ISO 10993:1 & other regulatory guidelines
· Genotoxicity test
· Sub-/acute and sub-/chronic systemic toxicological studies
· Sensitization test
· Irritation test
· Systemic toxicity testing
· Ocular biocompatibility test
· Implantation test
· Cytotoxicity test of contact lenses
• Episkin – skin irritation test
• Episkin – skin corrosion test
• In vitro skin sensitization
o Direct peptide reactivity assay (DPRA)
o Human cell line activation test (h-CLAT)
• The bovine corneal opacity and permeability (BCOP)
Advinus offers bioanalytical services for novel biologics and biosimilars including regulatory and non-regulatoryin vitro and in vivo studies
Currently Advinus offers:
IND Enabling Studies
NDA Enabling Studies
EpiSkin® Test in vitro Skin Corrosion & Irritation
Rodents and non-rodents
Tissue exposure kinetics in rodents
Dermal pharmacokinetics in rodents
Mechanistic pharmacokinetics models in rodents
PK-PD, modelling and simulations (WinNonlin approach)
Advinus has expertise in designing and synthesizing libraries of high purity synthetic compounds to support agrochemical discovery programs. Advinus offers this service on Full-Time-Equivalent (FTE) basis
Advinus is offering the regulatory services on the following apart from entire gamut of regulatory studies and are;
Advinus offers a wide range of DMPK services to support lead optimization and preclinical development. Advinus capabilities and track record include:
Advinus offers a full range of chemistry services for drug development at its Bangalore center spanning gram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development. The chemistry services are provided on both fee-for-service (FFS) and full-time equivalent (FTE) basis. Advinus clients range from academic institutions to small biotech to big pharma, and also agro chemical companies.
Chemistry Services include:
Advinus’ bioanalytical group specializes in quantitative LC-MS/MS method development, method validation and study sample analysis. Bioanalytical services are routinely provided for compounds in discovery, and in preclinical (toxicology) and clinical development. Fit-for-purpose bioanalytical methods are developed for discovery studies. GLP-compliant bioanalysis using fully validated methods developed are performed for studies conducted for regulatory submission.
The team has extensive expertise in developing sensitive methods for LC-MS/MS, including analysis of multi-analytes, metabolites, pro-drugs, and photo/temperature sensitive and ex-vivo instable compounds. Analytical methods for new chemical entities are routinely established and validated for rodent, non-rodent and human species.
Expert technical staff, advanced test equipment, Watson LIMS system (21 CFR Part 11 compliant), on-site Quality Assurance (QA) and rich experience in the area of bioanalysis enables Advinus to provide clients with timely bioanalytical services for both routine and complex studies.
Our experience and capabilities includes
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