SERVICES
As a result of constant technological innovation, the Regulatory Affairs Area has been extended in several aspects. That is why in Sanitary Regulation Experts, we are characterized by issuing a specific regulatory diagnosis to create comprehensive strategic plans according to the technical and legal particularities of each product from manufacturing to post-marketing.
We support entrepreneurs, new manufacturers, importers and distributors; As well as large companies.
Some of our main services:
Assembly
Management and follow up of paperwork
Dossier assemble for a variety of paperwork for COFEPRIS (Mexican MoH), among which are:
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Sanitary Registers (New, Modification, Renewal)
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Importation Notices and Permits
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Notices of Operation and Health Responsible
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Publicity Notices and Permits
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Health Licenses
Translation
Simple translation of technical documents. Certified translation of legal documents.
Management of Regulatory Affairs
- Regulatory Affairs Management
- Submission of paperwork in COFEPRIS
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Staff for the Regulatory Affairs Area for companies
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Full regulatory plans from manufacturing to post-marketing
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Implementation of technosurveillance
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Training in Sanitary Regulation and Health Topics
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Publicity Strategies for Health Products and Services
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Health Responsible for establishments
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Imports
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Advice for inclusion of products in the public health market