The Quality Assurance department at DEFI created reference manuals for Quality Management, Administration, Operation and Training, based on the Mexican Norm NMX-EC-17020-IMNC-2000 “Criteria for the operation of several types of units (organisms) that carry out some type of verification (inspection)” equivalent to the international guidelines ISO/IEC 17020:1998 to obtain the certification by COFEPRIS.
DEFI employees took tests at COFEPRIS on technical, normative and scientific aspects related to the sanitary regulation; it is important to mention that DEFI got the highest grades on the exams given to every applicant for Authorized Third Parties for both drugs and medical devices.
Our Quality Management System guarantees and independent, impartial, confidential, safe, efficient and comprehensive operation.
On December 15, 2011, The Certified Unit for Health Inspections DEFILATINA HEALTHCARE, S. A. DE C. V. (DEFI), obtains the authorization number. TA-111-11 to pre-validate dossiers for synthetic allopathic drugs and its modifications and renewals as well as the corresponding alterations to dietary and herbal supplements. This license was renovated with the authorization number TA-13-14 until February 2016.
On December 2013, DEFILATINA HEALTHCARE SA DE CV obtains the license to pre-validate medical devices.
In July 2015, DEFI´S chemists approved an exam to confirm their authorization for modifications and renewals review for dietary and herbal supplements.
In August 2015, DEFILATINA HEALTHCARE started the process to be certified as a licensed third party to review modifications of BIOLOGICAL and BIOTECHNOLOGICAL drugs, we will have the final approval by September 2015.
Quality Management and Operation System
DEFI has a highly qualified staff both in the academic and professional fields, approving the COFEPRIS exams with the highest scores of all applicants. On our team we have experts that have worked for the pharmaceutical industry in health regulation areas and in quality assurance.