GPS: N19° 17.884 W99° 11.364
Welcome to Global Active
Global Active cover all facets of the Health Regulatory Compliance Process in COFEPRIS for the various industry sectors in Mexico.
Regardless if your company is just starting off or well established in the Medical Device or Pharmaceutical Industry, Global Active can help you.
Medical devices; Pharmaceuticals, Complementary Medicines, Nutritional & Sports Supplements, Cosmetics and Toiletries and Herbal Products are regulated by the Secretariat of Health (Secretaría de Salud). According to Article 262 of the Mexican General Health Law the medical devices, Pharmaceuticals and Complementary Medicines must be registered or with the Secretariat of Health before marketing. The Federal Commission for Protection of Sanitary Risks (COFEPRIS) is in charge of registering any healthcare product. It permits licenses authorization and regulation. Its role is also standards developments, sanitary risk management and auditing vigilance and regulation compliance with law enforcement.
Our Regulatory Affairs Specialists offer advice on registration strategies to the medical device, pharmaceutical, complementary medicine, dietary supplement and related industries for more than 40 years, since the year 2001 acquired its present name: Global Active S.A. de C.V.
Global Active is a founding and active member of the council of the Mexican Association of Manufacturers and Importers of Medical Devices.
Our consultants have the expertise with Sanitarian Regulations in Mexico, are well-respected and have an excellent rapport with COFEPRIS. With Global Active as your partner, you will gain a deep understanding of the medical device or pharmaceutical industry regulations and requirements applicable often beyond what is available in published guidance documents and other materials.
Global Active will work with you to implement a effective regulatory strategy, and serve as your liaison from start to end, helping you to prepare the necessary documentation, respond to questions and negotiate with COFEPRIS.
Professional
Global Active Consulting has offered a professional and reliable service to all its customers, large and small, ensuring their confidentiality is respected at all times. Our years of proven results and a strong reputation, has set us apart from our competitors. We are also well placed for the expansion of the regulatory scheme to include complementary medicines and in-vitro diagnostics.
Global Active will consider the current regulatory environment, relevant guidelines, and ongoing COFEPRIS and/or international medical device and pharmaceutical initiatives that could influence your regulatory pathway. Our goal is to facilitate a timely, competitive, and successful product clearance or approval.
Competitive Rates
Our experience and knowledge ensure our clients always receive accurate and cost effective regulatory advice.
Medical Devices
The regulatory controls on medical devices were expected to increase significantly on commencement of the COFEPRIS Therapeutic Products Authority. It is expected that COFEPRIS will therefore introduce further regulatory controls on the distribution of medical devices.
The number of medical device regulations one must comply with during product development vary depending on several factors including the country where the medical device is being developed in and the kind of device being developed. Generally, medical device regulations are based on Risk. Our regulatory consultants have the expertise to help your medical device meet the many challenges of medical device regulations during the approval process, for products in Mexico.
We take every opportunity to provide input into proposed regulations and guidelines for medical devices and can provide advice on the regulatory controls as they become apparent. Global Active can prepare you and your facilities and/or documents for possible regulatory audits, including COFEPRIS inspections and registrar or Notified Body assessments.
Global Active consultants can support many types of medical devices: from active and non-active devices, including sterile and electromedical products, to in vitro diagnostics as well as drug-device combinations and borderline products.
We can provide:
* Regulatory Consulting.
* Regulatory Enforcement Corrective Actions, GMP Plans, Warning Letters, Complaints, Audits, other kind of notifications.
* Translation to Spanish of technical files & essential requirement documentation.
* Advice on best approach to transitioning devices to any new regulatory scheme.
* GMP and SOP's.
* Quality and Operational Manuals.
* Quality Manuals, GMP or Standard Operating Procedures.
* Internal Audits: documentary and the functioning conditions of the wharehouse of medical devices to comply with existing rules and regulations for Mexico.
* Supplier Evaluations.
* Requirements for devices with a chemical component.
* Submitting dossiers and paying fees on your behalf.
* Advertising compliance assessment.
* Intellectual Property Assistance.
* Trademark application.
* Import applications.
* Tecnovigilancia reports (Medical Device Post Market Surveillance).
Crisis Intervention
Are YOU presently concerned or involved in any of the following?
* Recently received a notice of a forthcoming COFEPRIS audit.
* Received a COFEPRIS Warning Letter.
* Received non-conforming observations from a COFEPRIS audit.
* Thinking about implementing a Corrective Action or Product Recall.
* Undergoing a Clinical Trial Investigation.
Contact us today to learn more about regulatory strategy development for medical devices. For additional assistance you may call (+52-55) 5812-8213 or You can use our online Contact Form to provide details of the product and specific needs.
Prescription/non-prescription Medicines
Both Prescription and Non-prescription (OTC) medicines require approval by COFEPIRS before they can be distributed in México. Additionally, medicines with approval that undergo material changes may also require COFEPRIS approval through a Changed Medicine Notification before these changes can take effect. We can advise you about getting your product approved and maintaining the currency of the registration.
Our regulatory affairs consultants can assure validation of the dossier, receive questions from the regulatory body and prepare suitable responses on your behalf, with your approval.
We can provide:
* Regulatory Consulting.
* Reviewing chemistry/pharmacy, preclinical and clinical texts and Preparing regulatory submissions.
* Advice and co-ordination for product development or product sourcing.
* New Medicine Application preparation, submission and follow-up.
* Changed Medicine Notification preparation, submission and follow-up.
* Preparation of medicine datasheets and consumer medicine information.
* Translation to Spanish of technical files & essential requirement documentation.
* Advice concerning product labeling and advertising.
* Preparing marketing authorization applications.
* Submitting dossiers and paying fees on your behalf.
* Intellectual Property Assistance.
* Trademark application.
* Farmacovigilancia reports (Medicine Post Market Surveillance).
Getting Started.
To get started, Global Active needs a list of the formulations you wish to import and label files (PDF format).
Contact us today to learn more about regulatory strategy development for pharmaceutical products. For additional assistance you may call (+52-55) 5812-8213 or You can use our online Contact Form to provide details of the product and specific needs.
Complementary Medicines, Nutritional & Sports Supplements, Cosmetics and Toiletries and Herbal Products
Complementary Medicines, Dietary or Sports supplements, Cosmetics and Toiletries, and Herbal or Natural products are controlled and regulated by COFEPRIS. We provide advice concerning compliance with these regulations in terms of labeling permitted ingredients in Mexico and acceptable claims (reviewing chemistry of components).
While we support the regulation of complementary medicines in Mexico, we recognize that such regulation should take into account the nature of the product and of inherent risks involved in their use. We take every opportunity to provide input into proposed regulations and guidelines for complementary medicines and products at the food/medicine interface and can provide advice concerning forthcoming regulatory requirements.
We can provide:
* Regulatory Consulting.
* Reviewing chemistry/pharmacy, preclinical and clinical texts.
* Translation to Spanish of technical files & essential requirement documentation.
* Preparing regulatory submissions.
* Advice concerning product labeling and advertising.
* Preparing marketing authorization applications.
* Submitting dossiers and paying fees on your behalf.
* Intellectual Property Assistance.
* Trademark application.
* Import applications.
Getting Started.
To get started, Global Active needs a list of the formulations you wish to import and label files (PDF format: nutritional facts, ingredients and claims).
Contact us today to learn more about regulatory strategy development for Complementary Medicines Nutritional & Sports Supplements, Cosmetics and Toiletries and Herbal or Natural Products. For additional assistance you may call (+52-55) 5812-8213 or You can use our online Contact Form to provide details of the product and specific needs.
