WE SIMPLIFY YOUR COMPLIANCE WITH

SANITARY REGULATION IN MEXICO

COMPLY WITH COFEPRIS EFFICIENTLY AND HASSLE-FREE
CONTACT US
RS-Garantizamos la Documentación Adecuada

Required Documentation

We guarantee the sanitary compliance of your products and establishment.

RS-Mantenemos al día con los cambios Normativos

Up to date with regulatory changes

Training and Updates

RS-Desarrollo de Proyectos

Expert Advice

Product Classification and Health Compliance in your labeling

RS-Desarrollo de Proyectos

Project Development

Compliance Strategies for Specialty Products and Large-Volume Projects

SANITARY REGULATION IN MEXICO DOES NOT HAVE TO BE A HEADACHE

We are your ally to achieve efficient and error-free compliance with COFEPRIS. We accompany importers, manufacturers and distributors in every step of the process.
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New and Generic Drugs

  • Application for Sanitary Registration.

  • Extension of Sanitary Registration.

  • Technical Modification.

  • Administrative Modification.

  • Prevention Response.

Herbal Remedies and Parenteral Nutrition

  • Extension of Sanitary Registration.

  • Technical Modification.

  • Administrative Modification.

  • Prevention Response.

  • Alphanumeric Key Request.

Food and Beverages

  • Formulas for specialized enteral feeding.
  • Review of COFEPRIS quali-quantitative formula.
  • Label design and review for FDA compliance.
  • Label design and review for compliance with COFEPRIS and NOM.
  • Addition of elements to the lists of additives and coadjuvants.

Dietary Supplements

  • Product classification inquiry.
  • Review of COFEPRIS quali-quantitative formula.
  • Label design and review for FDA compliance.
  • Label design and review for compliance with COFEPRIS and NOM.
  • Addition of elements to the lists of additives and coadjuvants.

Medical Devices

  • Product Classification Query.

  • Class definition.

  • Application for Sanitary Registration.

  • Extension of Sanitary Registration.

  • Technical Modification.

  • Administrative Modification.

  • Prevention Response.

  • Deregulation Consultation.

Cosmetics

  • Review of COFEPRIS quali-quantitative formula.

  • Label design and review for compliance with COFEPRIS and NOM.

Import and Export

  • Sanitary Import Permit.

  • Prior Sanitary Import Permit: Application, modification or extension.

  • Export Support Certificates.

Submitting Paperwork for your Business

  • Notice of Operation: Registration, modification or cancellation.

  • Notice of Sanitary Responsible: Registration, modification or cancellation.

  • Sanitary license: Issuance or modification.

Nuestros Clientes - Dispositivos Médicos Nuestros Clientes - Importadores y Exportadores Nuestros Clientes - Maquila de Alimentos y Bebidas Nuestros Clientes - Servicios de Salud Nuestros Clientes - Fabricantes de Cosméticos y Belleza Nuestros Clientes - Industria Farmacéutica Nuestro Clientes - Laboratorios Clínicos
Nuestros Clientes - Dispositivos Médicos Nuestros Clientes - Importadores y Exportadores Nuestros Clientes - Maquila de Alimentos y Bebidas Nuestros Clientes - Servicios de Salud Nuestros Clientes - Fabricantes de Cosméticos y Belleza Nuestros Clientes - Industria Farmacéutica Nuestro Clientes - Laboratorios Clínicos
We design and implement innovative strategies to obtain sanitary authorizations and make it practical for you to understand the current sanitary regulations.
Our service
is safe, easy
and 100% reliable!

Accredited by

  • Ensure that products comply with COFEPRIS laws and regulations.
  • Manage procedures to expedite their approval and submission.
  • We design fulfillment strategies for special or high volume products.

Contact us at

RS-Formulario de Contacto

Our Clients

Nuestros Clientes - Maquila de Alimentos y Bebidas

Food Industry

Nuestros Clientes - Importadores y Exportadores

Importers and Exporters

Nuestro Clientes - Laboratorios Clínicos

Clinical Laboratories

Nuestros Clientes - Industria Farmacéutica

Pharmaceutical Industry

Nuestros Clientes - Fabricantes de Cosméticos y Belleza

Cosmetics and Beauty Products Manufacturers

Nuestros Clientes - Servicios de Salud

Health and Beauty Services

Nuestros Clientes - Dispositivos Médicos

Medical Equipment Industry

Our services

Medications and Herbal Remedies

  • New Registration Application
  • Extension of Sanitary Registration
  • Technical modification
  • Administrative modification
  • Response to prevention
  • Alphanumeric Key Request

Medical devices

  • New Registration Application
  • Extension of Sanitary Registration
  • Technical modification
  • Administrative modification
  • Response to prevention

Dietary supplements

  • Product classification query
  • Label design, review and/or verification for compliance and commercialization

Cosmetics

  • Product classification query
  • Design, review and/or verification of label for marketing

Food

  • Product classification query
  • Design, review and/or verification of label for compliance
  • Support for the entry of additives list

Establishment

  • Registration of Notice of Operation and Sanitary Manager
  • Modification or cancellation of Notice of Operation and Sanitary Officer
  • Registration of Notice of operation of products and services
  • Modification to the Notice of operation of products and services
  • Issuance of sanitary license
  • Application and modification of sanitary license

Import and export

  • Sanitary import permit
  • Prior sanitary import permit
  • Export support certificates
  • Modifications to export support certificates
  • Application for Certificates of Free Sale

Product advice

  • Advice on national health regulations.
  • Product classification inquiry.
  • Design of strategies for obtaining health registrations and other authorizations.
  • Logistics of submission of paperwork to Cofepris.

Inspection Unit

  • Dossier Validation for drugs, herbal remedies and medical devices
  • Inspection of product labeling at customs or warehouse.

Training for companies

  • Regulatory framework applicable to health products and supplies.
  • Changes and modifications in laws, regulations, NOM’s and agreements.
  • Procedures and processes for obtaining sanitary authorizations.

Management of procedures with COFEPRIS

  • Obtaining an appointment before COFEPRIS.
  • Management for the entry of procedures and collection of available resolutions.
  • Documentary and electronic control and safekeeping.

Our customers

Pharmaceutical Industry

  • Transnational and national companies
  • Importers and distributors
  • Chain pharmacies

Food Industry

  • Groceries
  • Brewery
  • Tequila and mezcal
  • Self-service chains
  • Importers and distributors

SMEs

  • Farmers
  • Food and cosmetics manufacturers
  • Pharmacies
  • Independent businesses

Independent Clients

  • Positioning of new products in Mexico
  • Implementation of new businesses
  • Unrelated importers
  • Individuals
  • Health care professionals

Contact us at

Save time, our service is safe, easy and 100% reliable!
Schedule a consultation