Eurofins Advinus provides a comprehensive range of services to support Discovery, Preclinical and Early Clinical development programs. With 30 years of GLP experience we ensure reliability and accuracy of data with highest level of quality. Our team consists of multidisciplinary scientists with vast expertise in various novel, first-in-class targets as well as fast follow-on targets in various therapeutic areas. A number of assets worked on by our team have successfully completed preclinical development and some are in clinical development stage.
Eurofins Advinus has effectively and efficiently helped clients reach their development targets. We have completed 35+ integrated drug discovery programs. We have also completed 70+ IND packages, data for which has been accepted by various regulatory agencies (US-FDA, EU, HSI, MHRA, DCGI). In addition to accelerated IND programs our team has proficiency in NDA enabling toxicology studies. We offer a full range of process development manufacturing services spanning multi kilogram to MT scale for toxicology studies, clinical trials and commercial launch.
Our integrated service platform allows us to deliver the right service and the right time. With excellent communication and project management we guarantee easy flow of information between teams and on-time progress of your program. All this allows us to provide accelerated drug development through the R&D value chain.
Our successful candidate development and data acceptance by regulatory agencies is directly related to our experienced scientific team and is assurance that with Eurofins Advinus you can advance your programs with confidence.
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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