Espacio Regulatorio by Synergy

About Espacio Regulatorio

It is a space where we share health information, tips, industry information, as well as support the training of professionals and those who want to learn about the pharmaceutical, cosmetics, food supplements, food, establishments, etc. industry. With the purpose of sharing and contributing to public health and the required regulatory and technical compliance.

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Health Regulation

Assembling for medications registration dossier (normal and CTD).Assembling of modifications and renewals for medicines.

Assembling of medical devices dossiers.

Assembling for Medical device modifications and renewals.

GMPS and legal documentation.

Introduction to Pharmacovigilance.

Introduction to regulatory affairs.

Import permits through VUCEM.

Food regulation.

Cosmetics regulation.

Regulation of food supplements.

Regulation of Herbal Remedies.

Regulatory requirements for pharmacies.


Introduction for Health Managers.


Interpretation of NOM-164.

Interpretation of NOM-241.

Interpretation of ISO-13485.

Implementation of ISO 90001:2015.

Interpretation of GMP of cosmetics (NOM-259).

QMS Audits according to ISO-19011.

Good Storage and Distribution Practices.

Preparation of Quality Manuals and SOPs.

Critical Points of Validations and Qualifications.

Risk Management.

Critical Points of Validation of Computerized Systems.


Intellectual Property.

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