We provide comprehensive and qualitative services
tailored to the needs of our clients.

Services

Our continuous focus on research and analysis
ensures us to develop the right processes and the desired results for the clients.
Pharmacovigilance
  • Pharmacovigilance unit (outsource)
  • Call center
  • Risk Management plan / Risk minimization plan / Pharmacovigilance plan
  • Post-authorization safety studies
  • Designing protocol for PASS
  • Execution of studies (PASS)
  • Periodic safety update report
  • Preparation of ficha técnica - Mexico
  • Pharmacovigilance report
  • Safety report - Mexico
Technovigilance
  • Technovigilance (outsource)
  • Call center
  • Execution of Post-Approval studies (Medical devices)
Vaccine vigilance
  • Pharmacovigilane unit for vaccines (outsource)
  • Call center
  • Post-authorization safety studies (Vaccines)
Other services
  • Training
  • Medical writing
  • Pharmacovigilance unit (outsource)

    We help Pharmaceutical companies meet the legal and functional requirements to have a Pharmacovigilance unit for monitoring the safety of products that are marketed in the region.

  • Call center

    Call Center with inbound and outbound call service, staffed 100% by graduate health professionals, guarantees the clients the effective communication with Physicians and patients, reception & traceability of spontaneous reports on their products, correct analysis of information and monitoring of cases.

  • Risk Management plan / Risk minimization plan / Pharmacovigilance plan

    We help clients meet regulatory requirements of post authorization safety studies, right from preparation of Risk Management plans with a complete analysis of risk benefit analysis, risk minimization plan and Pharmacovigilance plan for the products that are being marketed in Mexico and in the region

  • Designing of protocol for PASS

    PPRO helps clients, drafting of protocols for Post authorization safety studies (PASS, observational, etc.), which can be industry-sponsored in compliance with regulatory requirements or investigator-initiated studies.

  • Execution of studies (PASS)

    In addition to the drafting PASS protocols, PPRO helps clients in the execution of those studies with our trained healthcare professionals right from initiation to completion of the study coordinating with participating physicians, healthcare staff and patients.

    In case of study execution, PPRO performs the following activities:

    • Initial training to the participants of the study
    • Coordination with patients, physicians and sentinel sites directly or monitoring the physicians and patients listed in the protocol and obtain the necessary information about the adverse events
    • Preparation and sending notifications of adverse events as per applicable regulatory requirements (NOM -220-SSA1 - 2012 in Mexico)
    • Analysis of the study results as per the requirements of the protocol and obtaining the safety profile of the product
    • Preparation of interim reports of the study executions for the submission to the regulatory agencies every 6 months following the start of the study
    • Preparation of the final report of the study with the aggregated results in compliance with the regulatory requirements
  • Periodic safety update report

    We prepare PSURs for the medicines that are marketed in Mexico and in the region following the product authorization complying with the timelines imposed by the respective regulatory agencies in Mexico and in the LATAM region with indepth risk-benefit analysis, new risk identified or any changes to the existing risk-benefit profile of the drug.

  • Preparation of ficha técnica - Mexico

    This document is part of the Periodic Safety Update Report presenting national level data on the safety of the drug in Mexico that are marketed in the corresponding period.

  • Pharmacovigilance report

    PPRO offers clients the service of Pharmacovigilance Report, which includes evidence of compliance of regulatory requirements with the regulatory authority (e.g.. Delivery of PSUR, Safety report - Mexico, Clinical Studies).

  • Safety report - Mexico

    PPRO helps clients prepare this document periodically (currently for every 5 years) with the aggregated information about all the adverse reactions reported following the authorization/renewal of authorization of the medicine.

  • Technovigilance unit (outsource)

    PPRO helps clients meet the legal and functional requirements of having a Technovigilance unit for monitoring the safety of medical devices being marketed in Mexico and in the region.

  • Call center

    Call Center with inbound and outbound call service, staffed 100% by graduate health professionals, guarantees the clients the effective communication with Physicians and patients, reception & traceability of spontaneous reports on their products, correct analysis of information and monitoring of cases.

  • Execution of Post-Approval studies (Medical devices)

    PPRO helps clients in planning and execution of Post-Approval studies (PAS) for Medical devices following the authorization of the product for marketing in Mexico and in the region.

  • Pharmacovigilane unit for vaccines (outsource)

    We help Pharmaceutical companies and healthcare providers meet the legal and functional requirements to have a Pharmacovigilance unit for monitoring the safety of vaccines that are marketed in the region.

  • Call center

    Call Center with inbound and outbound call service, staffed 100% by graduate health professionals, guarantees the clients the effective communication with Physicians and patients, reception & traceability of spontaneous reports attributed to the vaccination and immunization, correct analysis of information and monitoring of cases.

  • Post-authorization safety studies (Vaccines)

    PPRO helps clients in planning and execution of observational studies (PASS) to evaluate the safety profile of the vaccine following the authorization of the vaccine for marketing in Mexico and in the region.

  • Training

    PPRO offers individual or group trainings to clients on the topics of Pharmacovigilance, Technovigilance and Good practices in clinical research.

  • Medical writing

    PPRO helps clients in drafting any specific medical papers or articles related to Pharmacovigilance and safety of medicines, vaccines and medical devices as per their requirements.

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