Our Team and Experience
Our partners have worked in the pharmaceutical industry in the areas of Regulatory Affairs, Quality Assurance, Pharmaceutical Development, Logistics and Pharmacovigilance giving us vast experience in the pharmaceutical industry for over 20 years and have helped multinational companies navigate the cumbersome in country system of COFEPRIS.
Out team in Mexico is a young company formed by Pharmacist of great experience in the industry, they have supported and advised multinational companies such as AstraZeneca, Eli Lyli, Merck, Hospira, Schering Plough and Novartis.
Together our partners sum more than 40 years of experience in areas like Quality Control, Validations, Export/Import, R&D, Regulatory Affairs (Mexico and Latin America), Pharmacovigilance.
They have managed and helped companies with the development and implementation of international policies for SAP, Trackwise, BPCS, change control systems, product development and submissions.
With their experience and expertise our partners can offer your company innovative solutions.
|Regulatory Authority: COFEPRIS
Comisión Federal para la Protección contra Riesgos Sanitarios
Monterrey No 33 Col. Roma
C.P. 06700 - Mexico, D.F
Tel: 5080 5200
On July 5, 2001, the “Decreto de la Creación de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)" was published in the Official Gazette of the Federation. The decree established a decentralized administrative body of the Ministry of Health, with technical, administrative and operational autonomy, responsible for the exercise of the competences that exist in the field of regulation, control and health promotion according to the terms of the General Health Law, among other provisions. This new body was created by the General Directorate of Medicine and Technology for Health, Health Products and Services Control, Environmental Health, National Public Health Laboratory and Public Health Control Directorates, departments that were annexed to the Subsecretaría de Regulación Sanitaria y Desarrollo.