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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.

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

ALIANZAS ESTRATÉGICAS

PRISMA AGENCY
AMADIM
Mendoza Abogados

EXPERIENCE

CONTACT

Reforma 505, Floor 51, ZIP 06500,
Mexico City
Telephone: (+52 55) 5373-4316
roberto.oriol@cromcr.com
en.cromcr.com