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, establishment and management of procedures before COFEPRIS.

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 sanitary compliance in your labeling with specific strategies for authorization before COFEPRIS.

RS-Desarrollo de Proyectos

Project Development

Strategies for special products and large volume projects.

HEALTH 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.

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

CONTACT US

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.
RS-Formulario de Contacto

OUR CUSTOMERS

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

RECRUITMENT PROCESS

OF SERVICES

1. INITIAL CONTACT: The client contacts us through our official means.
2. EVALUATION AND STRATEGY: We analyze requirements and design the compliance plan.
3. PREPARATION AND MANAGEMENT: We gathered documents and filed paperwork with Cofepris.
4. FOLLOW-UP AND RESPONSE: We attend requirements until approval.
5. DELIVERY AND ADVICE: We obtain approvals and provide post-approval support.

We facilitate your regulatory compliance in Mexico!

COMPLEMENTARY SERVICES

Product certification

We guarantee that your products comply with the Mexican Official Safety Standards (NOM), ensuring their compliance with legal and quality requirements in various sectors.

Inspection Unit

We ensure compliance with the commercial information on your imported and domestic products, according to the guidelines established by the Mexican Official Standards.

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