services for pharmaceutical & medical device companies

We give you support in the fields of  Regulatory Affairs Compilation of Clinical Overviews and Clinical Summaries  (CTD Module 2.5 and 2.7) Compilation of Nonclinical Overviews and Nonclinical Summaries  (CTD Module 2.4 and 2.6) Renewals: Addendum to the Clinical Overview Pharmacovigilance: Risk Management Plan Expert Reports Creation and revision of product informations, SmPCs, PILs, QRD Template Literature researches Medical Devices: Clinical Evaluation according to MEDDEV 2.7/1 revision 4 [Clinical Evaluation Plan, Clinical Evaluation Report, Literature Search Report], Risk Analysis/Risk Evaluation Clinical Studies/Post Marketing Surveillance - Non-interventional Studies Planning, study protocol, CRF, patient information and informed conssent form, monitoring, data management, statistical consulting and analyses, final study report and publication Pharmacovigilance Trainings Development of training material with focus on your target group (ranging from medicinal laypersons to medical specialists) Marketing Creating of  promotion material