Compliance GxP, Mexico
CEO / GMPs, Audits & Regulatory Affairs
Pharmaceutical Chemist Biologist graduated from Mexican Autonomous National University (UNAM), Certified by Career and by Examination by the National College of Pharmaceutical Chemists of Mexico -COMECEF and Diplomat in Quality ISO 9001 by UNAM.
34 years of professional experience, 2.5 years worked at COFEPRIS, the last 13 years as a founding consultant of her company Compliance GxP® focused on the services of obtaining GMPs certificates, audits, drug products and medical devices submissions, implementation of quality systems, translations and training.
400 drug products submissions evaluated and 2,400 revised. 100 drug products submissions, 50 evaluations for the purchase and sale of inter-companies’ Market Authorizations, and 3 evaluations for the purchase and sale of pharmaceutical companies.
Certified Auditor in ISO 9001 by EQA, with more than 130 audits carried out at sites in Mexico and worldwide.
More than 50 inspections received from COFEPRIS, FDA, ANMAT, AMVISA and INVIMA.
34 years of professional experience, 2.5 years worked at COFEPRIS, the last 13 years as a founding consultant of her company Compliance GxP® focused on the services of obtaining GMPs certificates, audits, drug products and medical devices submissions, implementation of quality systems, translations and training.
400 drug products submissions evaluated and 2,400 revised. 100 drug products submissions, 50 evaluations for the purchase and sale of inter-companies’ Market Authorizations, and 3 evaluations for the purchase and sale of pharmaceutical companies.
Certified Auditor in ISO 9001 by EQA, with more than 130 audits carried out at sites in Mexico and worldwide.
More than 50 inspections received from COFEPRIS, FDA, ANMAT, AMVISA and INVIMA.
GMP’s certified trainer and speaker of the National College of Pharmaceutical Chemists of Mexico, Mexican Pharmacovigilance Association and Mexican Pharmaceutical Association.