Fokus e-health solutions
 
services for pharmaceutical & medical device companies

We give you support in the fields of 

Regulatory Affairs

Listing Compilation of Clinical Overviews and Clinical Summaries 
(CTD Module 2.5 and 2.7)
Listing Compilation of Nonclinical Overviews and Nonclinical Summaries 
(CTD Module 2.4 and 2.6)
Aufzählung Renewals: Addendum to the Clinical Overview
Aufzählung Pharmacovigilance: Risk Management Plan
Listing Expert Reports
Listing Creation and revision of product informations, SmPCs, PILs, QRD Template
Listing Literature researches
Listing Medical Devices: Clinical Evaluation Reports [DIRECTIVE 2007/47/EC; MEDDEV 2.7/1 revision 4], Risk Analysis/Risk Evaluation

Clinical Studies/Post Marketing Surveillance - Non-interventional Studies (AMG/MPG)
Listing Planning, study protocol, CRF, patient information and informed conssent form, monitoring, data management, statistical consulting and analyses, final study report and publication
Listing Pharmacovigilance

Trainings
Listing Development of training material with focus on your target group (ranging from medicinal laypersons to medical specialists)

Marketing
Listing Creating of  promotion material

home our services for pharmaceutical companies
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area for pharmaceutical companies
 
Fokus Dr. Panosch KG