Full accompaniment of pharmacovigilance and regulation for pharmaceutical companies

Our team is represented by scientists and clinicians with the appropriate qualifications (GCP, PhD certification confirmation).

We will determine for free whether it is possible to register drugs.

    AN APPROACH

    We solve problems

    CEO /
    Owner
    • Audit of the regulatory system and the status of the dossier
    • Turnkey procedures control
    • Pharmacovigilance function
    • Writing Clinical Development Plan
    Medical
    Director
    • Determination of the type of medicinal product
    • Preparing a dossier (medical writting)
    • Production licensing and GMP
    • Development and support of Clinical Development Plan
    QPPV and pharmacovigilance manager
    • Pharmacovigilance system audit
    • Medical writting - RMP preparation, DCO (AddCO), PSUR
    • Preparation of Pharmacovigilance and SOP System File Wizard
    • Creating and maintaining a hotline
    • Pharmacovigilance training
    Regulatory
    Manager
    • Determining the type of procedure
    • Medical writing - preparation of a review of preclinical data
    • Tracker of regulatory procedures
    • Development and support of Clinical Development Plan

    Registration of medicines

    • Registration and re-registration of medicines, medical devices, dietary supplements
    • Management of safety and quality of medicines
    • Licensing and certification of production

    Drug Safety Reports

    • We prepare reports on drug safety in 3 languages ​​- Russian, Ukrainian, English
    • Risk Management Plan (RMP)
    • Addition to the Clinical Data Review (ACO - Addendum to Clinical Overview)
    • Periodic Safety Report (PSUR - Periodic Safety Update Report)

    Reviews and resumes

    • Quality/Quality Overall Summary
    • Nonclinical Overview/Nonclinical Summary
    • Clinical Overview/Clinical Summary

    Pharmacovigilance

    • Authorized person responsible for pharmacovigilance - QPPV
    • Preparation of a master file pharmacovigilance system
    • Telephone hotline
    • Pharmacovigilance training

    Development

    • Roadmaps of preclinical, clinical research and registration
    • Preclinical and clinical trial protocols
    • Bio-statistics

    High-tech IT platform for pharmacovigilance and regulatory

    • Ability to simultaneously connect up to 100 users of one client.
    • Saving pharmacovigilance data in E2B r2 format.
    • Structuring data in CTD format
    • Access from any mobile device 24/7

    We help to prepare all the necessary documents for the registration of medicines, medical devices, dietary supplements, and cosmetic products

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