PRECLINICAL
SERVICES
Unparalleled technical excellence for complex preclinical studies
We provide the highest quality services for complex preclinical studies in large models of novel medical technologies, from early prototypes to fine-tuned devices for human clinical trials. Our people work with passion and provide unparalleled technical excellence to ensure high success rates while maintaining the highest ethical standards. We deliver superior outcomes, on time and within budget, as the needs of our clients are our priority.
What we offer
Our preclinical capabilities span from the earliest Proof of Concept studies through to final GLP studies that are conducted for submission to the US FDA and other regulatory bodies worldwide, pathology evaluation and clinical/investigator training with new technologies.
While we are perhaps most well-known for our world-leading expertise in complex cardiovascular procedures, we also have broad experience and capabilities across multiple non-cardiovascular disease areas as well.
Our unique, highly efficient and full-service approach saves money and reduces time to market with studies that are carefully planned, expertly conducted to the highest ethical standards and professionally documented. We excel in procedures ranging from early feasibility studies through to GLP studies to support worldwide regulatory approvals.
In addition, we have conferencing facilities and communications capabilities for on-site and remote, real-time, interactive procedure observation, allowing virtual participation by additional members of your team and for training and demonstration purposes.
OUR CAPABILITIES
Expertise in Preclinical Science
We have unmatched expertise in cardiovascular research, a space that demands a high technical standard. In addition, we also regularly complete studies in ophthalmology, thoracic surgery, neurosurgery, orthopedics, gastroenterology, dentistry, urology, fetal surgery and surgical robotics.
Preclinical Services
From early stage proof of concept to regulatory GLP studies for the FDA, cFDA or Notified Bodies. We help you with study design, model selection, protocol writing, medical device performance evaluation, pathology (macroscopic and microscopic evaluation), regulatory dossiers… A fully comprehensive and relevant integrated chain of services, convenient for you: one-stop shop for a higher efficiency, reducing time to market and costs for your medical device product development.
State of the Art Facilities
We offer a professional, hospital-environment technical platform to ensure a successful bridge from the preclinical to the clinical evaluation phase. We meet your preclinical research needs with cutting-edge technology.
ONE MINUTE
WITH THE EXPERT
PRECLINICAL
OUR LOCATIONS
Europe
Paris, France
42 Boulevard Jourdan
75014 Paris, France
MAIN CERTIFICATIONS AND GUIDELINES
The last FDA inspection and data audit to monitor Veranex Preclinical Services facilities’ compliance with the GLP requirements had a positive outcome: No concerns were raised by the Inspector.
After a thorough inspection and audit of our facility, the French national GLP compliance monitoring authority certified that Veranex Preclinical Services facilities in Paris are operating in compliance with the OECD Principles of Good Laboratory Practice.
- Strong experience in preclinical studies prepared for FDA and European Notified Bodies.
- All studies are performed according to basic “good practices” which imply high-quality standards. Moreover, studies can be performed according to Good Laboratory Practice (21 CFR part 58).
- Veranex preclinical facilities have all the authorizations and are fully accredited by the relevant French regulatory institutions in order to practice animal research.
- Veranex preclinical facilities are fully accredited by AAALAC International.
- At Veranex, preclinical research is at the level of practicing veterinary medicine: all studies and procedures are supervised by veterinarians (17 DVMs on staff).
- A Senior Veterinarian fully dedicated to animal care.
- Careful Ethics Committee oversight.
Looking for engineering and development support for your medical device?
LEARN ABOUT
OUR OTHER SERVICES
Preclinical Services
Global Clinical Research
Product Design & Engineering
Regulatory Affairs & Quality Management
Commercial Strategy & Market Access
