I. Marketing authorizations:
- Product classification
- Review, submission, and monitoring of records
- New records
- Technical and administrative modifications
- Renewal of registration
II. Other authorization processes:
- Import permits and requirements
- Document processing
- Advertising, labelling, and promotional materials
- Review for compliance with GMP certificates
- General alerts including operation, health officials, advertising, assembly, etc.
III. Quality management system
- Filling sanitary licenses
- Preparation and review of documents
IV. Audits
- Internal and external
- Training
V. Documentary platform
- Preparation of quality control document
- Preparation of operational procedures document
- Compliance awareness training
VI. Pharmaco & Techno vigilance
- Pharmacovigilance activities are required by the Mexican regulation, so drugs must be continuously monitored after approval in order to assess the long term safety profile in use