Servicios en Regulación Sanitaria

Dossier Conformation

​We have expert personnel in service of Dossier Conformation for Medicines, Herbal Remedies and Medical Devices.

In Mexico we are leaders in obtaining Medical Devices Sanitary Registration through all the agreements (FDA, Health Canada and Japan)

Trainings

We have developed training programs in health regulation, health products dossier conformation, Technosurveillance reports, legal frameworks and procedures, export and import of inputs, etc.
We participate in trainings with medical associations and chambers of commerce.

Custom counseling

In Mexico, we offer to national and international companies:
Legal representation as  Sanitary Registration Tittle holders to support them in the initial stage of their commercialization in mexican territory.
This representation includes compliance with current regulations, including those related to Technovigilance / Pharmacovigilance

Preclinical / Clinical Research services

​The Preclinical Research Unit (UNIPREC) supports industry and researchers, both with safety and efficacy testing for medicaments and Pharmaceutical Active Ingredients, as well as biocompatibility testing of medical devices and biocompatibility for biotech products.

In UNIPREC, we can support you to design preclinical phases that allow the decision to continue or interrupt in a timely manner the development of a drug, before investing large sums of resources.

UNIPREC seeks to demonstrate the effectiveness and safety of these products by integrating technology platforms in different areas of knowledge working under "Good Laboratory Practices".
For this reason, the new Research Unit requested to the Federal Commission for Protection against Health Risks (COFEPRIS) to act as an Authorized Third Party to conduct biocomparable tests of biotechnological drugs.

The UNIPREC account with a Quality Management System and Continuous Improvement system has five controlled quarters for Animal Experimentation with the highest environmental quality, as well as three laboratories: one for Cell Culture and Immunohistochemistry; One of Anatomic-Pathology and Clinical Pathology and one more of Immunology.