We provide a comprehensive range of services to support Discovery, Preclinical and Early Clinical development programs towards safety assessment and global regulatory registration. With 30+ years of GLP experience we ensure reliability and accuracy of data with the highest level of quality and customer satisfaction.
Strong R&D organization with
8 US Board Certified Toxicologists (DABT),
6 European Registered Toxicologists and
4 Board [Diplomate of Indian Board of Toxicopathology (DIBTP)] Certified Pathologists.
Bundesinstitute for Risikobewertung
W&V, The Netherlands
Indian GLP Authorities
(Since 2005)
OECD
AAALC
ISO
CPCSEA
CIBRC
DST
RCGM, DBT
AERB
Drugs Control Department
CDSCO
I am pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Tarus Therapeutics’ investigational new drug (IND) application for TT-4, a potentially first-in-class, oral Adenosine A2B receptor (A2BR) Antagonist. I commend Eurofins Advinus team for their highest quality of work and professionalism, understanding of regulatory requirements, and drive to resolve complexities during the TT-4 and TT-10 programs on early development, Chemistry Manufacturing and Controls (CMC) and preclinical IND programs in process optimization and development, ADME, formulation development, toxicology and toxicokinetics which contributed significantly to the timely preparation of a comprehensive data package and completion of the IND applications to the US FDA. It is my pleasure to recommend the highly experienced and enthusiastic Eurofins Advinus team for preclinical drug development and IND-enabling studies.
I would like to thank the entire Advinus team for their hard work and dedication. Recently, we have worked with Advinus on 2 INDs and both have been successfully submitted to US FDA. Advinus team is very dedicated and deliver a high quality reports and SEND data for IND submission. Team communication is excellent and they have very talented individuals with expertise in their field. I look forward to working with Advinus in future projects.
