CRO & preclinical consultant solutions I Versa Biomedical

Innovative services and solutions to take your preclinical studies further

At Versa Biomedical, we are dedicated to help you advance in your research and development goals.

Ad hoc solutions for unique needs

We are ad hoc solvers, with a precise custom-made process, covering specific and unique needs.
Powered by a solution-driven aim

We are experts in our field, rigorous and proactive, always willing to find the best solution
We are fully GLP certified

And compliant with the guidelines issued by ICH, ISO13485, EMA, ISO 10993, FDA and other relevant health authorities.
Committed to quality assurance

We prioritize quality at every stage of the development process, ensuring reliable results that meet regulatory expectations.

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customized preclinical trials
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Tailored preclinical development solutions

We provide ad hoc solutions for our sponsors/clients through in vivo studies using the swine model.

Whether you are embarking on drug discovery, developing a medical device, conducting safety and toxicity studies, or preparing for clinical trials, we are here to support you on every step of the way.

We tackle all kinds of challenges in two main areas:

01 / Biopharma preclinical trials

Versa Biomedical has experience in conducting in vivo preclinical tests for drug development, under GLP certification where needed. We support our partners from the very beginning of the preclinical phase through the development process, ensuring compliance with global regulatory requirements.

Proof of concept

We run preclinical studies that are essential to demonstrate the true validity of an approach.

Efficacy studies

We conduct tests to assess the efficacy of test items, tailoring the study plan to meet our sponsors’ specific requirements.

PK / TK

We run every kind of pharmacokinetic and toxicokinetic studies.

Preclinical toxicology studies

We investigate the response of drugs to evaluate their toxicity and safety.

02 / Medical device studies

We conduct in vivo studies to offer medical device development solutions. We support medical device companies to establish the best approach to run proof of concept of new devices and accompany them during all the preclinical development up to the regulatory phase.

As a Medical Device CRO we overcome the necessary steps to support a project during the regulatory submission of the preclinical testing, running them under GLP certification, when necessary. We accompany our partners all along the development process, from the prototype phase, efficacy trials, verification, validation and usability tests, to the regulatory biocompatibility and local and systemic in-vivo studies (ISO10993).

Proof of concept

We have the capabilities to conduct proof of concept studies using surgical instruments, implants, prostheses and other medical materials.

Efficacy studies

We perform studies using the pig model to verify the efficacy of medical devices in an animal model that closely resembles anatomically and physiologically a human patient.

Biocompatibility

We assess the biocompatibility of materials using in vivo pig models. Through these tests, we can determine the safety and potential incompatibility of materials when implanted in living tissue.

Safety

We run local and systemic safety studies. All preclinical tests conducted uphold the highest safety standards for both the animals and their handlers.

ISO 10993

We run studies to establish local and systemic safety, security, and biocompatibility of medical devices in accordance with ISO 10993 guidelines.

Usability tests

We can evaluate the usability of medical devices in real in vivo situations. Given that the pig model has dimensions similar to those of human patients, it provides an effective platform for these assessments.

We are experiment designers

At Versa Biomedical, we support our sponsors throughout all phases of their preclinical research projects, and we also offer the opportunity to advise them on the best design of their studies or experiments considering the particularities of the pig model.

We love facing new challenges, so we are glad to help to define and design new projects. What matters most is to formulate the right aims and questions, in order to obtain the best answers.

A whole process supported by experts

We have a wide team of collaborators and partners on different surgical services and expertise, that empower us with high competences otherwise difficult to achieve.

Thanks to them, human or veterinary medicine experts and surgeons, we provide the best know-how in each therapeutic area. We also open our doors to surgeons and experts provided by the sponsors to assist with the implantation or placement procedures.

01

Protocol & Authorization

Animal Welfare Body & Ethical Comitte
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Inclusion + Study execution

Surgeons and other experts

Histopathology, Bioanalysis, Specific test or imaging
03

Final report

Delegated phase final reports

Facilities

Fully equipped facilities to conduct high-quality preclinical trials for pharmaceutical, biotechnology and medical device companies, as well as research centres and hospitals, established both locally and internationally.

We provide the knowledge and experience of our multidisciplinary team in facilities that include 2,500 m² with housing areas, 2 surgical rooms, laboratories, research units and offices.

Our facilities