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Courses and Training

1.Regulatory issues
2.Quality

Regulatory issues

1.Advice for health registration, modifications and extension of medications

 

2. GAP analysis of Mexican registration dossier: review of the administrative-legal, chemical and BE or clinical
documentation


3. Advice for the presentation before the Committee on New Molecules


4.  Preparation and review of information for prescription and medicine labeling


5.Sanitary registry project management

Quality

1.Implementation of pharmacopoeial methods and stability studies


2.Preparation, updating and review of SOP´S

Av. Fray A. Alcalde 10, 44100 Guad., Jal., Mexico

55 4042 3749

Phone: +52-1-33-12345678

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