MCR - Marketing & Clinical Research

Marketing & Clinical Research is a Mexican company that provides services of 360º consulting to the health sector and the pharmaceutical industry. We have a team of specialists with extensive experience in:

Sanitary and regulatory affairs. Clinical research. Pharmacoeconomy and market access.
VISION

Be leaders as consultant of the pharmaceutical and health industry in Mexico.
Integrated by an interdisciplinary team, the innovation and personalization of our services on a proactive and a efficient way.
Mision

To offer integral solutions to meet the general and specific objectives of our customers within the pharmaceutical industry, public and private institutions and related national and international civil organizations in the health sector.

Regulatory
affairs
Clinical
research
Pharmacoeconomy
& market access
Legal
Services
Health
Supplies

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.

BUSINESS UNITS