Myriam Manager's Contact Details

Myriam Manager's Company Details

Fapner-Allianz

Mexico City, Mexico City, Mexico • 3 Employees
Pharmaceuticals

We are a Mexican Company that gather a group of highly trained regulatory affairs specialists to support our client's projects.Our services are aimed to support your business goals by providing regulatory support from technical translations to submission, for all kind of health productsOur Regulatory Affairs professionals can support you in tasks such as dossier ensemble, technical changes submission, administrative changes submission for Drugs, Medical Devices and other regulated productsMain Services:- Support and assessment for COFEPRIS submissions- Identification of Authorized Third Party- Submission Dossier revision and risk analysis - Regulatory intelligence support- Due Diligence- Regulatory strategy support- Dossier ensemble; - New Drug, Medical Devices and Health Products Marketing Authorization (registration). - Technical changes, - Marketing Authorization Renewal-Technovigillance support - Standard Operation Procedures, support - Product Reports- Technical Translations