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Accelerating MedTech Innovation: Top 10 Preclinical Service Providers in 2025

Veranex : Jun 9, 2025 12:39:47 PM

Preclinical

Characteristics of top-tier preclinical service providers

The journey from innovative concept to market-ready medical device requires rigorous scientific validation. Preclinical services represent a crucial (and often costly) phase in this journey, forming the bridge between early research and clinical trials or regulatory submission if a clinical or pivotal trial is not required. These services are not merely regulatory checkboxes. They can be significant value drivers that can make or break the development timeline, regulatory approval process, and commercial success of a new medical technology.

The most effective preclinical research not only demonstrates safety and efficacy, but also provides invaluable insights that can refine device design, especially in non-GLP or “pilot” studies, surgical techniques, future endpoints, and therapeutic applications prior to the initiation of human trials.

Evaluating and formally engaging a preclinical service provider is an activity to be done with rigor, especially when the most expensive preclinical study is the one that must be done twice.

As regulatory requirements grow more complex and the pace of innovation accelerates, the demand for cost-efficient, and comprehensive preclinical services has risen. MedTech innovators need partners who can deliver rigorous scientific evidence while adhering to aggressive timelines and navigating evolving regulations.

The most sought-after preclinical service providers distinguish themselves through key attributes that directly impact development success:

Therapeutic area expertise. Leading providers maintain deep expertise in specific therapeutic areas, with scientific teams that understand not just the regulatory requirements but the nuances of disease states, relevant animal models, and the translational challenges unique to each area.

Regulatory excellence. Top providers have established track records of successful regulatory submissions across multiple geographies, with teams experienced in navigating the requirements of the FDA, EMA, and other global agencies.

Comprehensive capabilities. The ability to support clients from early feasibility through Good Laboratory Practice (GLP)-compliant studies enables continuity and streamlines development by avoiding the inefficiencies associated with transferring projects between multiple vendors.

Operational efficiency. Leading organizations have optimized their internal processes to eliminate unnecessary delays while maintaining scientific rigor, enabling clients to accelerate the time to market without compromising quality.

State-of-the-art facilities. To keep pace with the speed of innovation, top preclinical service providers continuously invest in advanced technologies, from sophisticated imaging systems to specialized surgical suites.

Global presence. Providers with facilities in multiple geographies offer advantages in navigating regional regulatory requirements and can provide greater flexibility in study scheduling and execution.

AAALAC accreditation. AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) accreditation is a voluntary program that evaluates and accredits organizations using animals in research, teaching, or testing, ensuring they meet high standards of animal care and use. AAALAC is a non-profit organization that provides this accreditation. Accreditation demonstrates an organization's commitment to responsible animal care and use, meeting the "Guide for the Care and Use of Laboratory Animals" standards.

Top preclinical service providers

With those characteristics as a framework, we highlight below ten of the top preclinical service providers accelerating MedTech innovation.

1. Charles River Laboratories
As the largest preclinical CRO globally, Charles River Laboratories has established itself as an end-to-end service provider with extensive capabilities across multiple therapeutic areas, including oncology, neuroscience, infectious diseases, rare diseases, and inflammatory conditions. With more than 130 facilities in 20 countries, they offer significant capacity.i

Charles River is known for their comprehensive portfolio of research models, including patient-derived xenograft (PDX) and humanized immune system models and neurodegenerative and psychiatric disorder models. Their broad array of services includes discovery services, safety assessment, laboratory sciences, and scientific and regulatory advisory.

2. Veranex
Distinguished by its combination of comprehensive capabilities and specialized expertise, Veranex has rapidly emerged as an industry leader in preclinical services, supporting clients through non-GLP proof-of-concept studies through rigorous GLP-compliant research. Veranex integrates regulatory strategy into preclinical study designs from the beginning, ensuring that studies generate the proper data required to achieve a new product’s next critical milestone or regulatory submission while avoiding unnecessary work. Their strong regulatory expertise, supported by a dedicated team of regulatory and quality experts, allows them to anticipate questions before they arise, providing a seamless experience for clients.

Veranex states that its industry leading preclinical CRO services have supported over 100 regulatory submissions returned with no questions asked by regulatory reviewers; a significant indication of high proficiency in preclinical testing services.

With state-of-the-art facilities in North America and Europe, including preclinical labs in Paris and Atlanta, Veranex supports preclinical studies in large and small models across 11 therapeutic areas. The company has significant expertise in cardiovascular technologies and the preclinical studies that support them. These facilities and staff provide significant advantages in navigating regulatory requirements for multi-region submissions. The scientific teams at Veranex also excel at perfecting product designs, refining implant procedures, and optimizing delivery systems—, critical factors that accelerate advancement to human clinical trials.ii

In-house histopathology capabilities and sophisticated disease models enable clients to investigate both safety and potential clinical benefits early in development without having to separately engage another third-party saving time and money. This is crucial for refining product designs, implant procedures, and optimizing delivery systems, accelerating advancement to human clinical trials (if required).

3. NAMSA

NAMSA offers comprehensive preclinical services focused primarily on medical device and in vitro diagnostic (IVD) development, with expanded capabilities in combination products, biologics, and pharmaceuticals. In the last year, they have been involved in more than 1,650 medical device preclinical projects. A key differentiator of NAMSA is their Medical Research Organization (MRO) approach, which integrates laboratory, clinical, and consulting services.

Their therapeutic expertise spans cardiovascular, orthopedic, neurological, and gastrointestinal applications, with particular strengths in biocompatibility testing, toxicology assessments, and device safety evaluations. NAMSA also offers 20 fully equipped operating rooms and cath labs in the US and Europe.ii

4. Comparative Biosciences for Efficacy and Safety Testing (CBSET)

CBSET offers expertise in complex cardiovascular, endovascular, and other interventional medicine studies and has established itself as a leader of GLP-compliant testing services with unique capabilities in complex preclinical models. Their preclinical research capabilities integrate in vitro and in vivo studies, computational and 3D modeling, and histopathology into a single research paradigm. Their scientific team includes recognized MD and PhD experts who actively participate in study design and execution. CBSET is also known for its experience in developing and validating customized preclinical models that address specific client needs for novel therapeutic approaches where standard models may not be applicable.iii

5. Synchrony Labs

Synchrony Labs originated at Duke Medical Center and was formed as an independent contract research facility in 2001. Their therapeutic areas of focus include cardiovascular, gastroenterology, neurology, orthopedics, regenerative and wound healing, and vascular intervention. Synchrony Labs provides a wide array of preclinical services tailored to support medical device innovations, with a full range of advanced imaging technology and fast and flexible scheduling options such as night and weekend studies.iv

6. American Heart of Poland

Founded in 2000, American Heart of Poland is the top-ranked and largest privately operated cardiology-focused public healthcare services provider in Poland. Through their Center for Cardiovascular Research and Development, they cooperate with MedTech innovators in the areas of cardiology, cardiac surgery, vascular surgery, rehabilitation, and telemedicine. They provide imaging diagnostics, histopathology and other laboratory capabilities, experienced researchers, and an international network of reference centers.v

7. IRCAD Strasbourg

Since its creation in 1994, the IRCAD has gained global renown as a leading research and education organization with several institutes around the world. IRCAD France, located in Strasbourg, distinguishes itself through minimally invasive surgery expertise and advanced surgical training capabilities. They have a unique focus on image-guided surgical techniques including laparoscopic and robotic surgery, and their training facility welcomes over 8,800 surgeons every year.vi

8. BSL Bioservice Scientific Laboratories GmbH (BSL Bioservice)
BSL Bioservice is a well-established contract research organization (CRO) headquartered in Munich, Germany, offering comprehensive preclinical services with particular expertise in safety assessment and regulatory compliance. As part of the Curia (formerly AMRI) group since 2021, BSL Bioservice combines scientific rigor with global service capabilities to support medical device, pharmaceutical, and biotechnology development programs.vii

9. Skirball Center for Innovation (SCI)

Part of the Cardiovascular Research Foundation (CRF), SCI is a specialized preclinical research facility focused primarily on novel cardiovascular devices and techniques. They have developed expertise in the domains of interventional cardiology, structural heart disease, peripheral vascular disease, and neurovascular disease. SCI employs advanced imaging technologies and histopathology capabilities specifically optimized for cardiovascular applications and maintains close connections with practicing interventional cardiologists.viii

10. CVPath Institute

CVPath Institute, Inc. is a specialized preclinical research organization with extensive expertise in cardiovascular pathology and translational research. Founded by Dr. Renu Virmani, a renowned cardiovascular pathologist, CVPath has established itself as a leading authority in the evaluation of cardiovascular devices and therapies, with particular emphasis on histopathological analysis and mechanistic understanding of cardiovascular disease processes. They also maintain one of the world’s largest repositories of human cardiovascular autopsy specimens, helping to bridge preclinical models and human pathology.ix

Choosing the right preclinical service provider

Selecting the optimal preclinical partner requires careful consideration of multiple factors:

Therapeutic area alignment. Ensure the provider has demonstrated expertise in your specific therapeutic area. Ask for case studies, publications, and references from similar projects. The depth of experience in your particular indication can significantly impact study design, execution, and ultimately, results.

Need for specialization. Determine whether your program would benefit more from a comprehensive provider that can support the entire development continuum or a specialized provider with expertise in a specific niche. Companies with multiple programs often benefit from comprehensive providers that can support diverse needs.

Integration of regulatory strategy. The most valuable preclinical partners integrate regulatory strategy into study design from the beginning. This approach ensures that studies generate the data needed for submissions while avoiding unnecessary work. Providers with strong regulatory expertise can often anticipate questions before they arise.

Timeline considerations. Evaluate the provider's track record for meeting timelines and their capacity to accommodate your schedule requirements.

Target markets. For companies planning multi-region submissions, providers with global capabilities can offer significant advantages in navigating different regulatory requirements and executing studies according to various standards.

Communication and collaboration. The best partnerships are characterized by transparent communication and collaborative approaches. During initial discussions, assess how responsive the provider is and whether they offer strategic input rather than simply executing requested studies.

Conclusion: Top preclinical service providers should create value beyond the study

By selecting preclinical partners based on therapeutic expertise, comprehensive capabilities, and proven track records rather than simply cost considerations, MedTech innovators position themselves for more efficient development, stronger regulatory submissions, and ultimately, more successful commercialization.

Top preclinical service providers contribute value beyond simply executing protocols. They provide insights that improve device design, refine surgical techniques, and strengthen regulatory submissions. These contributions often justify premium pricing through acceleration of development timelines and increased probability of regulatory success. The highest-performing partnerships are forged when preclinical service providers function as true extensions of development teams.

To learn more about accelerated MedTech innovation with integrated scientific expertise, industry leading preclinical services, regulatory knowledge, and operational excellence, contact Veranex.