& market access
& market access
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 for products that do not require sanitary registration by COFEPRIS
Food and Beverages
Cosmetics and Beauty
SANITARY PUBLICITY PERMITS FOR PRINTED MATERIALS, RADIO, TELEVISION AND DIGITAL MEDIA
SANITARY IMPORTATION PERMITS
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.
Development of clinical trials.
Monitoring of clinical studies.
Elaboration of the expert report.
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.
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).
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
Reforma 505, Floor 51, ZIP 06500,
Telephone: (+52 55) 5373-4316