Medical advice and pharma-service are offered in the following areas by Dr. Dr. Heuer experts4pharma

Pharmacovigilance

• Processing and medical review /evaluation of individual case safety reports (ICSRs)
• Evaluation of safety signals and safety profile for a drug
• Writing of regulatory reports (e.g. PSUR, DSUR, RMP)
• Compilation and Revision of SmPC, CCDS, CCSI, Patient information leaflet (PIL)
• Clinical Overview Statements and risk-benefit evaluations for a changed safety profile
• Medical advice with respect to pharmacoepidemiology / safety aspects in clinical studies

Expert Reports

• Non-clinical & clinical Overviews; Non-clinical & clinical Summaries (CTD-format, Modules 2, 4, 5)
• Investigators’ Brochure (IB), Investigational Medicinal Product Dossier (IMPD)
• Non-clinical & clinical study reports
• Expert reports on phytopharmaceuticals, homoeopathic drugs, supplementary diets, medical devices, cosmetics and chemicals

Medical advice for preclinical and clinical Research & Development projects

• Medical advice, planning and evaluation for preclinical and clinical research & development projects
• Design and review of preclinical & clinical study protocols
• Advice on biopharmaceutical aspects

& more

• Medical & Scientific Writing
• Publications & journalism
• More resources and competencies via involvement of network of experts

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