De-Risk Development with Early Non-GLP Studies at Veranex
Starting with Non-GLP studies uncovers potential challenges early, reducing costly failures in GLP preclinical phases and human trials. Veranex's expertise and regulatory insight give Sponsors the clarity to make smarter, faster decisions—accelerating your path to market while minimizing risk.
Real-Time Innovation & Problem-Solving
-
Real-time protocol adaptation during live studies with on-the-fly decision making
-
Over 3,000 procedures per year providing extensive device optimization experience
Proven Startup Success & Grant Support
-
Student startup guidance from concept to commercialization
-
Grant support - helped secure $4.5M+ in government funding through quality preclinical data
Agile Partnership Approach
-
Flexible and responsive - matches client pace and budget unlike rigid academic environments
-
Scientific curiosity allows testing of new assays and techniques before GLP trials
The combination of real-time adaptability, proven startup success, and agile partnership approach demonstrates exceptional capability in accelerating early-stage device development to clinical readiness.
Non-GLP Preclinical Services: Accelerate Innovation from Concept to Clinical Readiness
Drive rapid device development and refinement with our flexible, expert-led preclinical research. Our veterinary surgeons and imaging specialists provide real-time problem-solving and design optimization to perfect your technology before advancing to GLP studies.
Non-GLP Study Types
- Proof of Concept Studies
- Acute and Chronic R&D/Feasibility Studies
- Early Device Development and Prototyping
- Delivery System Optimization
- Procedure Development and Refinement
Available Animal Models
- Large Animal Models: Swine (farm and minipig), Ovine, Bovine, Caprine
- Small Animal Models: Mice, Rats, Rabbits, Guinea Pigs
- Disease Models: Heart failure, acute MI, vascular pathology, kidney injury
- Human Cadavers (North America facility)
Innovation Support Services
- Product Design Troubleshooting and Improvement
- Real-time Protocol Adaptation
- Device Performance Testing
- Imaging and Data Collection
- Scientific Consultation and IP Development
Advanced Capabilities
- State-of-the-Art Imaging: CT, MRI, 3D Fluoroscopy, Echocardiography
- Hybrid Operating Rooms with full cath lab capabilities
- Remote Collaboration via secure streaming platform
- Rapid Study Turnaround with flexible scheduling
What Clients Say
"There are significant portions of preclinical and GLP requirements that the Veranex team knows that we don't: not only in their knowledge of study subjects, and administration of a GLP study, but also follow up tests and biometrics that are commonly included in regulatory submissions."
Senior Director of Product Development, Leading Medical Device Company
What Clients Say
“Thanks to guidance from our preclinical partner and university mentors, we refocused on the right questions, solutions, and activities with commercial success and clinical improvement as the ultimate goal. We don't just want to make something that works. We want to make something that works in a way that people need and want it to work, and something that providers will actually pay for."
University-Based Medtech Startup
What Clients Say
"The ability to conduct fundamental and translational studies in small and large animal models in the same location with a highly qualified preclinical staff who understand our needs and our science was the final piece of the puzzle."
Principal Investigator, Academic Medical Center
Our Expertise
Therapeutic Areas for Non-GLP Studies
Cardiovascular

Vascular Intervention

Neurosurgery and Neuromodulation

Targeted Drug Delivery

Gastroenterology and Urology

Orthopedics

Maternal-Fetal Health

Ophthalmology

Regenerative Medicine and Wound Healing

Related Articles
Latest Blog Entries
Meet the Team
Meet Our Leaders That Will Make Your Non-GLP Study A Success
Nicolas Borenstein, DVM, MsC, PhD
Senior Vice President, Preclinical Services
Nicolas Borenstein serves as co-president of preclinical services, with extensive expertise in surgical and transcatheter preclinical science, particularly in cardiovascular and non-cardiovascular medical devices. A widely published author and peer-review journal reviewer, Nicolas combines academic excellence with hands-on surgical experience. He completed his veterinary medical and surgical training in Paris and Fort Collins, CO, earned his MSc in Surgical Science under Professor Alain Carpentier at Broussais Hospital, and received his PhD summa cum laude from University Paris Cité. His additional qualifications include specialized certifications in microsurgery, experimental surgery, and animal research from prestigious French institutions.
Luc Behr, DVM, MsC, PhD
Senior Vice President, Preclinical Services
Luc Behr serves as co-president of preclinical services, bringing more than 20 years of experience as a recognized thought leader in preclinical science. His deep expertise in surgical and transcatheter medical device design, combined with advanced medical imaging competencies, has helped hundreds of companies innovate sophisticated medical technologies and implant procedures. Luc's comprehensive understanding of the preclinical regulatory landscape complements his technical expertise. He completed his veterinary medicine degree and surgical residency at École nationale vétérinaire d'Alfort, followed by both his MSc and PhD in stem cell research from University Paris Cité, with additional training at The University of Missouri College of Veterinary Medicine.
Jeff White, DVM
Senior Vice President & Scientific Director, Preclinical Services
Jeff White serves as senior vice president and scientific director of preclinical services at Veranex, bringing extensive executive leadership experience in medical technology innovation and product development. Throughout his career, he has successfully led organizations through startups, mergers, acquisitions, and turnarounds, driving cumulative revenues exceeding $250M and contributing to over 70 FDA regulatory clearances and approvals. His expertise spans U.S. and international (GxP) regulations, strategic planning, and business development, with particular emphasis on building and managing high-performing teams across matrix-based academic, industry, and private equity-backed organizations. He holds a Doctor of Veterinary Medicine from Kansas State University and a Bachelor of Arts in Biology from The University of Kansas.
Sherry Farrugia
Senior Vice President, Preclinical Services
Sherry Farrugia serves as senior vice president of preclinical services at Veranex, bringing exceptional leadership experience in healthcare and life sciences innovation. Her distinguished career includes serving as CEO of T3 Labs and a decade at the Georgia Institute of Technology, where she led both the Global Center for Medical Innovation (GCMI) and the Pediatric Technology Center (PTC). Under her leadership, she has driven the commercialization of numerous medical devices, secured 90 funded projects, and generated multiple patents. A five-time Georgia Bio Award winner, including the prestigious Industry Growth Award, Sherry was named Women of the Year in Technology in 2018 and received the President's Award for Excellence in Multidisciplinary Team Research. She holds a BS in Chemistry and Physics from Auburn University and a certificate in global innovation from the University of Oxford.
Case Studies
Real World Impact at Veranex
Adapting Preclinical Protocols in Real Time: Product Development Firm Supports Novel Cardiovascular Therapy
Situation
A cardiovascular pharmacology expert at a prominent academic institution developed a novel therapy aimed at reducing reperfusion injury after myocardial infarction. This therapy specifically targets the four primary sources of reactive oxygen species (ROS). Having secured early-stage grant funding, the expert sought a preclinical partner capable of simulating realistic clinical conditions and refining protocols for optimal translational relevance.
Successes
- The product development firm advised a crucial protocol modification, shifting from intravenous to intra-arterial administration, to more accurately reflect clinical delivery methods.
- During an active study, the firm's team made a critical real-time decision to delay test agent administration after numerous defibrillation shocks. This mirrored real-world clinical judgment and maintained the integrity of the study.
- The initial test compound demonstrated a 70% reduction in infarct size and a notable improvement in cardiac function when compared to control groups.
- This collaboration significantly accelerated the therapy's readiness for subsequent grant phases and positioned it for long-term survival studies and eventual clinical translation.
Services by Veranex
- Preclinical protocol development and refinement
- In vivo myocardial infarction model execution
- egulatory-aligned study design and randomization
- Support for grant progression
From Concept to Commercialization: Innovator's Journey to Transform Spinal Access with Product Development Firm Support
Situation
What started as a university capstone project to mitigate complications arising from epidural misplacement has evolved into Innovator, a medical technology startup dedicated to real-time spinal needle guidance. With assistance from their university's entrepreneurial program and a product development firm, the team successfully navigated the intricate path from initial concept to market readiness.
Successes
- Innovator strategically shifted from an initially compatible prototype to a universally compatible system, a decision driven by valuable clinician feedback and market demands.
- A substantial grant secured funding for development and preclinical testing, which included four cadaver studies conducted at the product development firm. These studies demonstrated significant improvements in procedural metrics.
- The team has achieved a functional prototype and is now preparing for regulatory submission, with manufacturing transfer and verification testing on the horizon.
- Innovator acknowledges the product development firm's responsiveness and expertise as vital in enabling first-time entrepreneurs to maintain focus on commercial and clinical success.
Services by Veranex
- Preclinical feasibility and cadaver study execution
- Study protocol design and technical guidance
- Real-world operating room simulation
- Mentorship and commercialization support
- Regulatory strategy alignment and readiness
Ready to Accelerate Your Medtech Vision?
Transform your early-stage device concept into a clinical reality with our agile, expert-driven non-GLP preclinical research services.
Testing and Prototyping
Testing and Prototyping
Ensure your innovative design performs flawlessly and meets critical standards. Our comprehensive testing services are backed by dedicated facilities and advanced equipment, allowing us to assess any product type with various levels of rigor.

Quality Services
Quality Services
Build quality into your medical device from the ground up. Our integrated quality services are essential for navigating complex requirements and ensuring your product is developed to the highest standards for a safe and effective device.

Regulatory Services
Regulatory Services
Navigate the complex regulatory landscape with confidence. Our regulatory experts are integrated into your product development process, providing the strategic guidance needed to anticipate requirements and streamline your path to approval.

Human Factors
Human Factors
Design intuitive and safe devices that truly meet user needs. Our human factors expertise is critical in product development for ensuring your device is designed around the user, minimizing risk and enhancing the overall experience for patients and practitioners.

Non-GLP Preclinical Expertise That Will Accelerate Your Medtech Vision.
Transform your early-stage device concept into a clinical reality with our agile, expert-driven non-GLP preclinical research services.



