Unrivaled Preclinical Services

Accelerating Your Innovative Research

When it comes to ensuring world-class design and conducting your MedTech and biotech preclinical studies in large models, Veranex provides recognized expertise based on the validation of medical devices used to treat more than 1 million patients. Whether your study is a complex cardiovascular procedure or focused on another disease area, we provide a wide range of industry-leading knowledge that guides 3,000 procedures and 1,000 implantations per year.

Our full-service approach saves you money and reduces time to market with carefully planned, professionally documented studies performed to the highest ethical standards. We excel in procedures ranging from early feasibility studies through Good Laboratory Practice (GLP) studies that support worldwide regulatory approvals.

With an unrivaled record of successful completion of sophisticated studies with novel interventional or surgical technologies, we have the background to bring you results. Explore how our deep in-house surgical expertise, state-of-the-art FDA-validated facilities, and innovative thought leadership can benefit your study.

See our Preclinical Newsletter: IMMReview

Meet the Preclinical Services Experts

1000000 +

Patients treated to date with medical devices validated at Veranex

3000

Procedures/year

1000

Implantations/year

2500 +

TAVI to date

1400

TMVR to date

200

TTVR to date

For Preclinical Services That Exceed Your Expectations, Veranex Is Your Difference

SERVICE AREAS

High Efficiency to Reduce Time to Market and Costs

We believe that the early stage is key for the development of medical innovation, and early R&D projects require flexibility and immaculate attention to detail. We provide consultative expertise and maintain strict procedures to protect the confidentiality of your technology, results, and intellectual property. Veranex guarantees complete service with rigor, adaptability, and on-time performance. Our client-oriented, efficient team is trained to manage the unexpected events often encountered in early studies. Veranex works with companies around the globe who perform their core R&D studies with us because of our unique capabilities and approach.

Optimize outcomes with a well-designed preclinical strategy and protocols

Our extensive evaluation capabilities, including validation and bench testing, are delivered in state-of-the-art, FDA-inspected, and AAALAC-accredited facilities. Our expertise is unparalleled in the successful completion of sophisticated studies of novel medical and surgical technologies. Veranex’s unique, highly efficient, and full-service approach saves money and reduces time to market with studies that are carefully planned, professionally documented, and expertly conducted to the highest ethical standards. We excel in procedures ranging from early feasibility studies through Good Laboratory Practice (GLP)-compliant studies to support worldwide regulatory clearance/approvals.

We also provide in vivo preclinical evaluation in large models (ISO 10993, ASTM International, EMEA guidelines, and FDA recommendations), including the earliest stage proof-of-concept studies, R&D stage studies during which product designs are iterated and perfected, and final, regulatory studies intended for regulatory submissions. Macroscopic and microscopic pathology evaluation is performed in-house to provide further critical information regarding biological responses to a medical device or biomaterial. All studies intended to support regulatory submissions are performed according to GLP guidelines (21 CFR Part 58, OECD). As required, those include the use of written protocols, standard operating procedures (SOPs), calibrated equipment, accredited facilities, study conduct by skilled and trained personnel, and proper data tracking, biostatistics, and preparation of formal study reports.

Pristine Data Under Constant Scrutiny of Our Quality Assurance System

Veranex has all the authorizations from and is fully accredited by the relevant French regulatory institutions in order to conduct research in large models, and we are FDA inspected and validated.

Our institutional Animal Care and Use Committee ensures that studies performed at our facility are conducted in compliance with the Guide for the Care and Use of Laboratory Animals and in accordance with European Community recommendations.

More advanced studies and those intended to support regulatory submissions are performed according to Good Laboratory Practices (21 CFR Part 58). As required, those include the use of written protocols, standard operating procedures, calibrated equipment, accredited large model facilities, study conduct by skilled and trained personnel, and proper data tracking, biostatistics, and preparation of formal study reports.

Quality assurance is of paramount importance in our daily work. Our technical expertise in the operating room is necessary but not sufficient for our clients’ success. They need compelling and enduring results. Achieving these results requires the collection of pristine data subject to constant scrutiny, verification, validation, interpretation, and archiving in conjunction with a robust quality assurance system. We follow Good Laboratory Practices to ensure that our work conforms to the highest professional standards in preclinical research.

Expert In-House Macroscopic Assessment and Histologic Evaluation

Veranex is committed to being a world-leading, science-driven center of excellence in medical and biotechnology preclinical research. As part of the assessment of the safety, performance, and efficacy of a new biomaterial or device, our pathology department offers an integrated, comprehensive, state-of-the-art, and GLP-compliant portfolio of services that includes sample processing, evaluation, interpretation, and reporting.

Comprehensive Planning and Hosting Services for Your Training Event

Whether for investigators, clinicians, or sales representatives, surgical training is a must for novel medical devices and biotechnology. Veranex’s Paris facilities can dedicate up to five operating suites simultaneously to training sessions tailored to the specific needs of our clients. We have state-of-the-art and fully equipped technical platforms identical to those that would be encountered in a hospital setting, providing a familiar environment and experience that can be applied to clinical use. Our Paris facility offers an attractive and comfortable environment for productive training events.