Our outstanding professional team has extensive experience and active participation with all relevant stakeholders of the Health and Life Sciences sectors, which allows us to offer our clients comprehensive advice that cross-cuts all areas of its regulatory spectrum. With specialists in Bioethics, Biomedical Research, Human Rights, Health Regulatory and Intellectual Property, we offer our clients services that cuts across all activities related to health, from the design and research of new health products to its registration and commercialization.

Services in this area:

•  Advice on Biomedical Research.
•  Protection of clinical data and inventions for pharmaceutical and medical device products, among others.
•  Sanitary Registrations.
•  Support on health alerts generated by pharmacovigilance and techno-vigilance procedures.
•  Commercial defense in cases of unauthorized competition.
•  Formulation and handling of complaints before the competent authorities.
•  Advice and support on personal data.

Soley Saborío - Abogados is a relevant and recognized actor in the “bioethics research ecosystem of Costa Rica”; We normally participate in the creation of new regulations and actively participate in public hearings to evaluate amendments, improvement, and creation of new legislation. Our participation has been widely recognized by various actors in the legislative process of approval of the current Biomedical Research Regulatory Law, as well as in the preparation of new regulations for the authorization of therapeutic procedures with stem cells.

Nowadays, we are part of a Task Force made up of the Academia, members of Scientific Ethics Committees, professionals with extensive experience in biomedical research and other significant stakeholders, for the preparation of a proposal for the regulation of biomedical research with medical devices as well as a proposal to reform the Regulation to the Regulatory Law of Biomedical Research.

Some of the projects that we had participated on, include:

•  Regulations of Reagents for Clinical Trials.
•  Requirements for the Importation, Marketing, purchase, and sale of Reagents for Clinical Trials.
•  Requirements for the importation of vaccines.
•  Requirements for the importation of medical devices.
•  Monitoring of laws and regulations that are of interest for the improvement of the investment climate in the Health Sector.