Dossier preparation (drugs, medical devices, obtaining alpha-numeric key for herbal remedies, recognition of orphan drugs), as well as equivalence procedures.

This service consists of the request and evaluation of the legal and technical information required to obtain the sanitary registration of the input that is the reason for the request, as well as the information for modifications or extensions of sanitary registrations. Advice during the conformation period to support the client in the generation or request of the required information, as well as to establish regulatory strategies. Additionally, we carry out the elaboration of labels, registration project, application form, clarification letters and all the information required to be presented in the dossier. We print all the information to be included in the dossier and prepare the dossier based on the requirements of the administrative-legal and technical modules. We support in the processing of apostilles before the Mexican authority and in the request of certified copies.

Electronic procedures through DIGIPRiS

Submission of self-managed and electronic procedures. We provide support in the request and generation of documents or files with the characteristics requested by the platform to facilitate their uploading

File preparation (printing and foliage)

If you have all the information required to submit an application to COFEPRIS, we support you with the printing and foliation of the dossier to conform it and deliver it ready for submission to the authority. Additionally, we make a backup of the file (mirror copy) for delivery to the client.

Registration or change of operating notification

This service consists of requesting the information for registration, filling out the form and submitting it to COFEPRIS through the DIGIPRiS platform.
The Notice of Operation applies to those establishments described in art. 200 Bis of the General Health Law (LGS).

Elaboration of Technovigilance Reports (ITV)

Technovigilance Report: It is the document that contains information related to the safety and efficacy of medical devices that are marketed or used in national territory. This is an indispensable requirement for the renewal of the sanitary registration, which must be submitted 3 months prior to the extension request.

Labeling and formulation evaluation: medical devices, drugs, cosmetics, herbal remedies and dietary supplements

Formulation evaluation is carried out based on the applicable regulations to determine permitted concentrations, prohibited substances, additives and coadjuvants. Additionally, the purpose of use can be evaluated to determine the type of input in question.

Elaboration of consultations to COFEPRIS for food supplements

This service consists of reviewing the general information of the product (indication of use, formula, presentation) to determine if it is considered a food supplement. Subsequently, we prepare the official letter with the supporting information for the entry of the consultation to COFEPRIS so that the authority can determine by means of an official letter that the product complies with the characteristics established in the applicable regulations.

Hosting Services

Additionally, we have strategic allies to provide legal representation services in Mexico (Mexican Registration Holder), for those medical device manufacturers abroad that do not have a representative office in our country.
Among the activities and responsibilities of a holder are:
- Act as the legal holder of the medical device sanitary registration. - Filing with COFEPRIS requests for sanitary registrations, extensions or modifications. - Responding to COFEPRIS requirements and audits on behalf of the manufacturer. - Technovigilance activities.

Elaboration and referencing of IPP (Information for Prescribing)

Review of the Drug Information for Prescribing against supporting documents (clinical studies, CCDS, scientific articles, etc.), and referencing of each section of the IPP, as applicable

Sanitary licenses

Support for the processing of sanitary licenses before COFEPRIS for establishments dedicated to health supplies, environmental health and health services.

Audits (Good Manufacturing Practices for drugs and medical devices; distribution warehouses, manufacturing of medical gases) and GAP analysis.

We conduct both in-person and virtual audits at manufacturing sites and distribution warehouses of various health supplies, to verify compliance of their good manufacturing practices with applicable Mexican regulations.

We have experts in audits under FDA criteria. We perform GAP analysis under the current NOM-241-SSA1 and NOM-059-SSA1 to evaluate the compliance of the applicable establishments and define the action plan to follow.

Prior import permit for health inputs (VUCEM)

This service consists of reviewing the general information of the product (indication of use, formula, presentation) to determine if it is considered as a food supplement. Subsequently, an official document is prepared with the supporting information to be submitted to COFEPRIS so that the authority can determine by means of an official document that the product complies with the characteristics established in the applicable regulations.

Main Services

We offer support for obtaining authorizations from COFEPRIS regarding health supplies and other products regulated by the sanitary authority.

Registration of Medical Devices with COFEPRIS

Who We Are

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What our clients say

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Jennifer Lewis

Boston

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Janice Moore

Tampa

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Laura Richi

New York

Health and regulatory solutions for your business

Do you need advice on paperwork, regulatory compliance or sanitary regulations?

Our team of experts is ready to help you.

Contact us at

We solve your doubts and advise you

We support you

Dossier preparation (drugs, medical devices, obtaining alpha-numeric key for herbal remedies, recognition of orphan drugs), as well as equivalence procedures.

Electronic procedures through DIGIPRiS

File preparation (printing and foliage)

Registration or change of operating notification

Elaboration of Technovigilance Reports (ITV)

Labeling and formulation evaluation: medical devices, drugs, cosmetics, herbal remedies and dietary supplements

Elaboration of consultations to COFEPRIS for food supplements

Hosting Services

Elaboration and referencing of IPP (Information for Prescribing)

Sanitary licenses

Audits (Good Manufacturing Practices for drugs and medical devices; distribution warehouses, manufacturing of medical gases) and GAP analysis.

Prior import permit for health inputs (VUCEM)

Main Services

What our clients say

Jennifer Lewis

Janice Moore

Laura Richi

Health and regulatory solutions for your business

Contact us at

Contacto

Redes sociales

+1 840 841 25 69