SIDAR, S.A. DE C.V. offers the complete services of a Regulatory Affairs Direction, formed by skillful personnel with more than 10 years of experience in their specific area.
We have an Interdisciplinary Advisory Committee who reviews and plans the regulatory strategy for your projects along with the specialist person, who is in charge of the Project, in order to achieve your objectives in the best way.
Our focus is on meet your requirements with 100% quality and be on your side always.
- Market Authorization, (Review, translation and dossier compiling with the Check list requested by MOH and the fulfillment of the formats)
Finished Products
- Generic
- Biologics (Vaccines)
- New Molecules
- Biotechnology
Others (Dietary Supplements, Nutraceuticals)
Medical Devices
- Class 1ª
- Class I
- Class II
- Class III
- Bioequivalence and Clinical Trials (Clinical Monitor, Planning and coordination in our CRO or at Third Party of your choice)
- Generics
- New Molecules
- Import & Export Licenses
- Finished Products & APIs
- Products & Services - Medical Device
- Patents (Consulting, Research, Non-infringement Letters, FTO by our Specializing Lawyer in Patents, Trademark & Intellectual Property Data Rights)
- Control and Quality Assurance (Consulting, Planning or Follow up)
- AMT or TT
- Stabilities
- Validations
- Quality System, CAPA
- Audits of Good Manufacturing Practices (Pre-check and / or preparation for audits, support during the audit with the services of a Chemist – Specialized in translation (English – Spanish).
- Manufacture Laboratory of Finished Products
- Manufacture Laboratory of Active Pharmaceutical Ingredients
- Distribution Warehouses
- Pharmacovigilance
- PSUR - RMP
- Advertisement
- Advertising Licenses
- Sanitary Responsible Person – (Responsable Sanitario in Spanish, is a legal figure that is Quality Responsible before the authority of the products marketed)
- Distribution Warehouses
- Pharmacies
