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 preparationMedical/Safety Monitoring
SAE reporting
Safety Analysis and Reporting
PSUR/DSUR preparation
Medical MonitoringScientific Communications
Manuscripts
Editorial support
Journal/conference submission
Educational scientific materials
Medical marketing reviews and reports