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BUSINESS UNITS

REGISTRATION OF MEDICINES AND MEDICAL DEVICES, INCLUDING:

  • Integration and review of dossiers for registration.
  • New registrations, Modifications and Renewals, tracking each request until its conclusion.
  • Comprehensive advice for post-registration processes that allow the marketing of medicines and medical devices registered.

SANITARY NOTICES

  • Sanitary notices for products that do not require sanitary registration by COFEPRIS
  • Alimentary supplements
  • Food and Beverages
  • Cosmetics and Beauty

SANITARY PUBLICITY PERMITS FOR PRINTED MATERIALS, RADIO, TELEVISION AND DIGITAL MEDIA

SANITARY IMPORTATION PERMITS

  • Customs services

SANITARY LICENSES

  • Architectural design and engineering focused on sanitary licenses.
  • Advice and support in the compliance of good practices of medicines, medical devices and other health supplies.
  • Elaboration of Normalized Operating Procedures according to good manufacturing practices standards, both national and international.

RESEARCH SERVICES

  • Development of clinical trials.
  • Monitoring of clinical studies.
  • Pharmacovigilance.
  • Pharmacoepidemiology.
  • Elaboration of the expert report.
  • Laboratory tests.
  • Bibliographic research and meta-analysis.
  • Search for updated information.
  • Analysis of product profile.
  • Detection of product strengths.
  • Recommendations dor positioning.
  • Home visits, Monitoring visits and Closing visits.
  • Evaluation and selection of research sites for studies phase I to IV.
  • Monitoring of clinical studies phases I to III.
  • Monitoring of studies phase IV
  • Scientific Medical Review and Regulatory Justification of a Bioavailability protocol.
  • Scientific Medical Review and Regulatory Justification of a protocol phase I to IV.

PHARMACOECONOMY

  • Economical Evaluation of medicines, programs, devices and other medical technologies.
  • Construction of the economical models, decision tree, Markov models.
  • Probabilistic and / or deterministic probability analysis.
  • Identification and obtaining of parameters and costs of effectiveness, utility, minimization and cost - benefit.
  • Analysis of budget and impact.
  • Development of promotional support software (interactive models).

MARKET ACCESS

  • Portfolio evaluation: Private Market and Goverment.
  • Feasibility analysis for inclusion in goverment.
  • Development of strategies for inclusion in goverment sales.
  • Sales Inclusio to Federal Health Institutions: IMSS, ISSSTE, Seguro Popular, SEDENA, SEMAR, PEMEX.
  • Coordination of Advisory Boards High specialty
  • Support in shared risk schemes

Legal Services

  • Support in answering requirements and precautions issued by COFEPRIS.
  • Filing of appeal for review against negative resolutions before COFEPRIS.
  • Filing of contentious administrative trials before the Federal Court of Administrative Justice, against resolutions issued by COFEPRIS.
  • Filing of protection lawsuits against suspensions or closings or imposed security measures.
  • Generation of strategies to obtain authorizations based on legal arguments.

Health Supplies

    MCR has a wide catalog of health supplies applied to various branches of the health industry resulting from strategic alliances with production plants and distributors at the national and international level.
    We currently have scopes applied to:


    Clinical laboratory

  • General equipment for all types of clinical laboratory
  • Serological / Rapid Tests.
  • PCR Equipment - Nucleic Acid Isolation Systems.
  • Extraction PCR tests - Magnetic Bead Method
  • PCR tests - Fluorescent probe method.

    Supplies for pandemic

  • Triple Layer Thermosealed KN95 with NYCE certificate.
  • KN95 con certificado NYCE.
  • Sanitizing Mist Services.
  • Devices for detection of microbiological contamination in workspaces.

STRATEGIC ALLIANCES

PRISMA AGENCY
AMADIM
Mendoza Abogados

EXPERIENCE

CONTACT US

MCR

Av. Paseo de la Reforma 505
Torre Mayor, Piso 51

Mexico City, CP 06500
cromcr.com