Dossier assembly Ordinary way or FDA equivalency agreementNew Registration Class I - Low Risk,Class I, II, III
Technical or Administrative Modification, Class I, II, III
Extension Class I - Low Risk,Class I, II, III
Dossier validation
We validate the administrative, legal and technical documentation of the file, in order to corroborate that it meets the criteria established by the Health Authority of Mexico, prior to procedure entry before COFEPRIS through the assistance and effective communication with the personnel involved during the process.
Registration, Modification or cancellation of the
unit Responsible for Technovigilance
We manage the documentary requirement in which the Health Authority is informed that there is a Technovigilance Unit (responsible for developing and implementing activities related to medical devices safety and efficacy and it is informed who is the only valid interlocutor in terms of Technovigilance to the CNFV (Responsible for Technovigilance).
Installation of Technovigilance Unit (SOP and/or
Training)We develop the standard operating procedures (SOP), to carry out in a reproducible way all the activities of the Technovigilance Unit, with the aim of guaranteeing that the medical device before and after marketing works or is used according to its indication and instruction of use. Or otherwise, the corresponding actions are taken to correct or decrease the probability of recurrence of adverse incidents.
Technovigilance ReportsWe prepare the documentary report regarding the monitoring of a medical device that has a Sanitary Registry marketed or used within the Mexican territory in a period of 5 years, based on documentary evidence for certain quality, safety and efficacy of your medical devices.
SOP diagnosisWe carry out a general analysis to detect the points of improvement in the Technovigilance Unit that must be implemented, updated or modified, base on the current statutes established by the Health Authority to avoid detection of a finding by such authority.
Dossier assemblyNew Molecule Registration fraction I to VI, Generic fraction I to VI, Herbal and Vitamin.
Technical or Administrative Modification of the New Molecule fraction I to VI, Generic fraction I to VI, Herbal and Vitamin.
New Molecule Extension fraction I to VI, Generic fraction I to VI, Herbal and Vitamin.
Dossier validation.
We validate the documents issued by the manufacturer, prepare the administrative requirements requested by the Health Authority of our country and integrate the corresponding documents in the file prior to entering COFEPRIS to obtain the Sanitary Registration, modification of the registration or extension.
Registration, Modification or
Cancellation of the Unit or Responsible for Pharmacovigilance
We manage the documentary requirement by which the Health Authority is informed that there is a Pharmacovigilance Unit (responsible for providing information on the clinical practice, necessary to establish a better safety profile of the marketed medicine in Mexico and activities related to the prevention and minimization of risks derived from the use of a medicine) and you are informed who is the only valid interlocutor in terms of Pharmacovigilance to the CNFV (Responsible for Pharmacovigilance).
Pharmacovigilance Unit Installation
(SOP and/or Training).
We develop the standard operating procedures (SOP) to carry out in a reproducible way all the activities of the Pharmacovigilance Unit; with the purpose of implementing processes aimed at detection, identification, quantification, evaluation and prevention of the possible risks derived from the use of a medicine to support its safety and efficacy.
Periodic Security Report.
We prepare the crucial document, which provides the evaluation of the benefit / risk balance of a medicine in relation to a defined applicable period and after the authorization of the Sanitary registration or product marketing.
Risk Management Plan.We develop the document that includes information on the safety profile of a medicine, which describes the measures to be taken to monitor, prevent and minimize risks.
SOP Diagnosis of the
Pharmacovigilance Unit
We carry out a general analysis to detect the points of improvement in the Pharmacovigilance Unit that must be developed, updated or modified based on the current statutes established by the Health Authority in order to avoid detection of a finding by such authority
Implementation of the Quality
Management System (optional ISO 9001: 2015),
(SOP and/or training)
We design and develop the Standard Operating Procedures that allow to adopt strategies and methodologies to carry out in a reproducible way the different operating processes of your company through organization, planning and execution of the activities necessary for the development of the organizational mission by complying with current Sanitary legislation generating high quality standards, which are measured through the indicators of user satisfaction or internal and external audits respectively.
Quality Management System AuditsWe carry out a systematic, independent, and documented process to obtain evidence and evaluate them objectively in order to determine the level at which the criteria are met established by the Sanitary Authority and stipulated in its continuous improvement processes.
Quality Management System Diagnosis.We carry out a general analysis to detect the improvement points in the different processes operations that must be implemented, updated, and / or modified in your quality management with the aim of giving you confidence and assurance that supplies for the health or service of which they are providers comply with the established standards.
Registration, modification, or cancellation Warehouse of Health Supplies.
Distributor of Health Supplies
Establishment (tattoo artists, piercers and micropigmenters)
Manufactures of medical devices or herbal remedies
Dortor's Office
Products and services
Ambulance services
Pharmacy (allopathic, homeopathic) or drugstore.
We manage the initial document for some specific documents, which, occupies a preponderant place within the procedures that are regulatory competence by COFEPRIS. Likewise, it is managed before COFEPRIS all the modifications or cancellations that you wish to make derived of its operational processes. With this provision, Article 200 bis of the General Law of Health is complied, which states: "Notice of Operation must be given by Establishments that do not require sanitary authorization and that, by agreement, are determined by the Health Ministry...".
Tattoo artists, Piercers, and MicropigmentersEvaluation and assistance to obtain the Sanitary Control Card.
We manage the document that allows you to practice modification procedures to physical appearance through tattoos, piercings or micropigmentation so that your clients have the confidence that you apply the necessary measures to protect their health.
Sanitary licensesSupplies for health:
Manufacture, warehouse and distribution of medicines and / or biological products for human use.
Pharmacies with controlled medications (it includes control books registration).
Environmental health:
Manufacturers of pesticides, plant nutrients and toxic substances.
Urban pest controllers using pesticides.
Import of tobacco products.
Health services:
Establishment that uses radiation sources for medical or diagnostic purposes (X-rays, nuclear medicine, radiotherapy).
Hospital.
Regenerative medicine establishment.
We support the file Assembly that is entered into COFEPRIS, so that this Authority generates authorization to carry out activities related to human health, based on the requirements determined by the General Law of Health and other applicable general provisions.
Sanitary Regulation of food supplementsConsultation to COFEPRIS.
Formulation review.
Label Review.
We develop an analysis according to the qualitative-quantitative formula, label and allowed substance or additives, integrating the necessary documentation to verify that it complies with the legal framework of a food supplement and submit the classification consultation to COFEPRIS obtaining a favorable response.
Establishment preverification.To obtain the Certificate of Good Manufacturing Practices.
Act through which we carry out a pre-verification visit to the establishment to inspect its facilities and processes in accordance with the current applicable regulatory framework and prepare a list of findings so that they can carry out corrective or preventive actions processes, facilities or equipment, with the sole objective of that the health input does not represent risks to the health of consumers or users and therefore when they receive a health visit, give formal compliance to obtain the Certificate of Good Manufacturing Practices.
Notices and advertisement permissions.We evaluate the advertising material of your product or service and collect the necessary information to integrate a file that complies with the advertising guidelines and applicable health regulations, with truthful content, linked to liability social, verifiable, clear and ethical for the target audience; either in the media conventional or digital, with the sole objective of not jeopardizing the health of the population and consequently obtaining the advertisement notice or permission issued by the Health Authority, avoiding fines, product assurance or suspension of activities of the establishment for being detected spreading irregular advertising.
Import licenseWe carry out a documentary process to obtain the instrument that allows products that are subject to the requirements of the Health Ministry to enter the country legally.
TranslationsSimple translation into Spanish.
Simple translation into Spanish (express).
Technical translation made to the set of documents issued in language English. The translation is done directly in editable PDF or Word, trying to keep the format and pagination identical to the original, delivering it ready for printing.
TrainingWe teach a set of educational activities in your facilities to strengthen weaknesses detected in the regulatory field improving their processes and reducing costs, for example, training in the medical devices dossier assambly, by FDA equivalency agreement, interpretation of IEC laboratory tests, strategy to submit evidence of biocompatibility, etc.
In Situ developmentInteractive, didactic and trust-generating process that allow you to carry out the evaluation of the information or documentary development in your facilities when you want to generate certain confidentiality measures, implement a strategy derived from the contribution of different areas, physically assess the progress of a project, by visit of the manufacturer and other applicable characteristics that you as a customer want.
