Medical consultancy -



“NEED FOR EFFICACY AND SAFETY OF THE PRODUCT” Medical writing of regulatory documentation: - Clinical Overview and Summary (all legal basis applications) - Non-clinical Overview and Summary (all legal basis applications) - Clinical Study Reports (CSRs), protocols, Investigators brochures (IBs), safety narratives - Enviromental Risk Assessment - SmPC, PIL - Bridging reports (readability) - Writing of medical / pharmaceutical publicatons for journals Medical writing in Pharmacovigilance: - Company Core Data Sheet, Company Core Safety Information - Periodic Safety Update Reports (PSUR / PBRER) - Risk-benefit reports - Signal detection - Risk Management Plan (RMP) - Medical assessment of adverse drug reactions - Medical Enquiries Medical advising / promotional activities: - Pre – or post – launch strategic medical/scientific advising - Advising on promotional scientific content and communication plan - Communication with key opinion leaders on behalf of the customer