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DEVUM Research has team of medical and pharmaceutical experts which is experienced and well versed with pharmaceutical development to produce clear and concisely worded documents for medical and pharmaceutical companies. Based on our industry experience and regulatory interactions, we are able to prepare a diverse range of medical and pharmaceutical documentation to address the needs of various stakeholders. Find below highlights of scientific documents we offer:

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  • Regulatory Support

    Regulatory queries response
    FDC regularization
    Clinical an Non-clinical sections of CTD
    SEC/FDC committee presentations/documents
    NLEM and DPCO queries response
    Food product regularization (fssai)

    Clinical Research (Phase I-IV, BA/BE)

    Clinical Trial / BE study Protocol Development
    Case Report Forms
    Investigator Brochure
    Informed consent Forms
    Statistical Analysis Plan
    Statistical Analysis Report
    Clinical Study Report
    Regulatory Dossier preparation

    Medical/Safety Monitoring

    SAE reporting
    Safety Analysis and Reporting
    PSUR/DSUR preparation
    Medical Monitoring

    Scientific Communications

    Editorial support
    Journal/conference submission
    Educational scientific materials
    Medical marketing reviews and reports