The process to start a review with us is the following:
1. Signing of confidentiality and service agreements by both parties.
2. The user requests DEFI a quote by e-mail describing the process to be reviewed.
3. The user accepts the quote issuing a purchase order to DEFI for this review.
4. DEFI sends the user a specific checklist of all the documents the dossier must contain so that when it is submitted to review it is organized, correct and complete.
5. The user submits the dossier directly to DEFI. The client has the obligation of keeping an accurate copy of the delivered file.
6. DEFI evaluates the viability of the dossier through a quick review.
7. If the initial evaluation is positive, DEFI receives the dossier in its offices under confidentiality conditions and a dossier submission document is signed.
8. DEFI evaluates the dossier according to the criteria agreed in the training course offered by COFEPRIS and other legal technical dispositions that may apply (LGS, RIS, Norms, etc.).
9. The dossier review takes around 30 business days during which, DEFI will send the user a weekly report listing the findings and requesting documents or corrections needed to obtain registration by COFEPRIS.
10. The user may visit DEFI any time to create complete the dossier from the requested documents in order to comply with all the requests that DEFI needs to write a favorable Technical Report. DEFI cannot include or remove any document without the client being present.
11. If after 6 months of submitting the dossier to DEFI, the client has not been able to comply with all the observations made to its dossier, DEFI will return the file to the client considering the project complete.
12. Once all observations have been achieved, DEFI issues its favorable technical report in the forms authorized by CAS and bags the binders in special bags to be submitted to CIS by the Authorized Third Party Lane. DEFI keeps a copy of the ITF and the other copy will be given to the user for its submission to CIS along with the dossier. COFEPRIS does not allow the user to keep copy of the ITF.
13. The user takes the dossier and technical report to the COFEPRIS offices and delivers it through CIS in the special lane for Authorized Third Parties.
14. All verdicts or technical reports issued by authorized third parties in pre-verdict of registration/alterations should be favorable.
15. If during the review of the favorable reports issued by authorized third parties, COFEPRIS finds any reason to issue prevention, they will call DEFI to schedule a technical appointment to which the user may attend if COFEPRIS considers it is necessary.
16. COFEPRIS is constantly evaluating the performance of each one of the authorized third parties. Authorized third parties are obligated to submit periodical bi-annual reports to COFEPRIS.
17. COFEPRIS commits to deliver registrations in half the time that what is established by law.