REYES & REYES ABOGADOS has outstanding experience in the areas of regulatory and public health affairs. Our expertise in these areas comprises counseling clients in the design and development of successful legal strategies, aimed at increasing the chances of success in the various procedures conducted before the public health, regulatory, and other authorities, including investigations at the national and local level.
Regulatory and Public Health Affairs
Services
- Operating permits, public health, and Good Manufacturing Practices (GMP) issues.
- Representation in administrative and penalty proceedings before the Ministry of Public Health, the INVIMA [Colombian National Food and Drug Administration], the Superintendency of Industry and Commerce (SIC) and territorial regulatory agencies, among others.
- Counseling and representation in administrative investigations and penalty proceeding conducted by the Deputy for Technical Regulations and Legal Metrology of the Superintendency of Industry and Commerce – SIC.
- Support in penalty proceedings and public health security measures, ordered by INVIMA, in matters related to the safety and efficacy, packaging, advertising, and promotion of pharmaceuticals, be they prescription or over the counter (OTC) products.
- Counseling on matters of regulations and compliance.
- Counseling on price control related issues, for pharmaceuticals and medical devices.