All our Auditors are Certified ISO 109011:2011 and fully trained on GMP Regulations, each one with more than 20 years of experience in the Pharmaceutical Industry for both, the manufacturing of Pharmaceuticals and APIs.
More than 5 years of experience performing National and International GMP Site Visits approved by the Mexican Health Authorities.
Audits performed to Pharmaceutical Plants (allopathic and homeopathic), APIS plants, Distribution Warehouses, Medical Devices and Cosmetic Plants.
Our services include:
- Consultant services via internet or on-site, to interpret the new requirements
- Diagnostic Audits in order to evaluate the compliance level of your plant against the new requirements, and prepare you for new COFEPRIS Inspections
- Training sessions virtual (english) or at your site on Mexican GMPs, and how to attend a COFEPRIS Inspection (new approach)
- Coaching during COFEPRIS INSPECTION, in order to assist you with language issues and to deal with observations made by the inspectors before generating the final Report/Act, looking for the best results to be achieved
- Coaching to answer any “PREVENTION LETTER” or additional information requested by COFEPRIS after an inspection, in order obtain the Re-certification.
We assure in each one of our services, effectiveness, customized to your needs and value added to each one of our customers.