Our Services

Bussiness lines & Products

HUMAN USE

  • Medicines
  • Medical Devices
  • Herbal Remedies
  • Cosmetics
  • Dietary Supplements
  • Food, Alcoholic and Non-Alcoholic Beverages

VETERINARY USE

  • Medicines
  • Dietary Supplements
  • Food

COFEPRIS ESTABLISHMENTS

  • Warehouses and Distribution
  • Medical Offices
  • Pharmacies
  • Clinics

    SENASICA ESTABLISHMENTS

    • Warehouse
    • Manufacturing site
    • Authorized Veterinary Responsible

    Services

    Consultacy

    • Review of Establishments.
    • Regulatory Strategies.

    Contentious Lawsuits

    • Extraordinary means to challenge administrative obligations to resolve specific procedures.

    Materials

    • Editing, revision and elaboration of arts or labeling of medicines, food, dietary supplements, cosmetics.

    Health Council

    • Inclusion or modification of codes in the National Compendium of Health Supplies.

    Establishment

    • Implementation of QMS, obtaining ISO 13485:2016 Certification, COFEPRIS GMPS, Licenses, among others.
    • Verification of facilities.
    • Audits.
    • Support in the management of safety measures.

    Procedures before COFEPRIS

    • Preparation of dossier of New Registration, Modifications and Extensions.
    • Alphanumeric code of Herbal Remedies.
    • Classification of Dietary Supplements.
    • Advertising Notices and Permits.
    • Import Permits.
    • Notice of Operation and Sanitary Responsible.
    • Among others.

    Procedures before SENASICA

    • Notice of Beginning of Operation.
    • Veterinary registrations.
    • Veterinary Food Authorization.
    • Free Sale Certificate.
    • Certificate of Origin.
    • Import Permits.
    • Authorized MVZ responsive.
    • Verification of establishments.

    NOM-024 Health Information Exhange Certification

    • NOM-024 certification obtention with NOM-024-SSA3-2012 Electronic Health Record Information Systems. Health Information Exchange with the DGIS.

    Warehouse & Distribution

    Holder/Legal Representative

    Our warehouse and distribution service with notice of operation for the wholesale sale of medicines fraction IV, V and VI, as well as medical devices are at your service.

    • Legal representation of holders abroad (foreign-manufactured medicines).
    • Sanitary Registry Holder (Medical Devices).

    We review the options that adapt to your projects and needs, always with regulatory compliance.

    Includes:

    • 24 hour surveillance
    • Pharmacovigilance and/or Technovigilance Unit
    • Operation Notice with the possibility of obtaining a Health License for handling controlled products.

    TYPES OF WAREHOUSES IN THE HEALTH INDUSTRY FOR HUMAN USE:

    • Raw material
    • Cosmetics
    • Food supplements
    • Medicines
    • Medical devices

    If you require veterinary use, please indicate so to help you find the best option.