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 say that overall our experience with Eurofins Advinus has been very positive at all times. From the perspective of a small biotech like Origo, Eurofins Advinus fulfils all our requirements: flexibility, adherence to pre agreed timelines, adequate quality for the stage of development and no cost deviations! Our experience with them has been mostly on the IND packages including API and regulatory Toxicology. The approach the team of chemists has always been very proactive, looking for solutions, and keeping in mind the balance of quality vs time which is critical at early stages in development.

I would like also like to highlight that, the teams at Eurofins Advinus made a very significant effort to minimize the impact in timelines during the very difficult times of the COVID pandemics, we value this effort very much and are extremely grateful.

I would like to thank the entire Advinus team for their tremendous support in the submission of two INDs with the US FDA. The Advinus team performed multiple in vitro and in vivo IND enabling studies with the highest scientific quality while meeting very aggressive timelines. The Advinus team displayed outstanding scientific competence and professionalism in conducting studies, and the quality of study reports was top notch. Their “can do” attitude was much appreciated and I look forward to collaborating with Advinus in future projects.

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.

Revere has had a first-rate and productive partnership with Eurofins Advinus, Bangalore, India for over 2 years. During this time, we have performed ADME/DMPK and IND safety assessment studies at Eurofins Advinus. The team was highly experienced, professional, and enthusiastic, providing scientific insights and communicating effectively, while addressing any technical challenges during the engagement period. Amid the COVID pandemic, all our timelines were met, and the quality of the data and reports were excellent. We are extremely pleased with the services provided by Eurofins Advinus for our preclinical drug development program and IND-enabling studies and would enthusiastically recommend their high-quality services to others.

The Eurofins Advinus team has shown excellent performance in progressing the chemistry and delivering critical compounds which have helped us in advancing the project and answering very pertinent hypothesis to understand the SAR. The team deserves appreciation for meeting deliverables par excellence, even through the scale-up synthesis in a brief period with high quality and purity for advancing in-vivo-studies.

We are happy to work with the Eurofins Advinus team since the beginning of our project. We find professionalism, reactivity and proactivity in anticipating potential issues and resolving them in short time. The asset produced meets international standards of quality (non GMP and GMP).

We have had an excellent partnership with Eurofins Advinus for over 6 years. During this period, we have performed several IND enabling studies that were accepted by the regulatory agencies (US-FDA, HC, EMA) and these programs are currently undergoing PoC clinical trials. In addition, post IND we have conducted subchronic and chronic toxicity studies including genetic toxicity, DART and carcinogenicity studies each supported with excellent analytical and bioanalytical capabilities. We are extremely happy with the proficiency of the team and the quality of data meets the international standards. We are pleased with the services provided by Eurofins Advinus and look forward to our continued collaboration.

I am pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared 7 Hills Pharma’s investigational new drug (IND) application for 7HP349, a first-in-class, oral integrin activator for solid tumors.  A large part of the preclinical development work comprising CMC, ADME/DMPK and toxicology/safety assessment was outsourced to Eurofins Advinus Limited, Bangalore, India. We are pleased with the experience, professionalism, capability and enthusiasm of the Advinus team in completing this work. Their professionalism, understanding of regulatory requirements, and drive to resolve complexities faced during the 7HP349 preclinical development program in ADME, formulation development, toxicology and process development contributed significantly to the timely preparation of a comprehensive and compelling IND application to the FDA.  It is my pleasure to recommend Advinus for preclinical drug development and IND-enabling studies.

We (including our associate companies) have had a very extensive and triumphant relationship with Eurofins Advinus (erstwhile Advinus Therapeutics) for the past 11 years. They have been our preferred partner and act like an extension of our own R&D team. Over this time, 12 full IND development projects have been awarded to them and of these 10 have been completed while 2 are ongoing, which is a testimony to our confidence in them and their commitment to us. We found the team of scientists extremely competent and capable and often capable of exceeding our expectations. The team pays attention to details (timelines and quality) and ensures flawless transition of the project through various workstreams during project execution. We unreservedly recommend them for your IND development and CDMO needs.