Pharma Consulting Services

Readability User Testing of PILs Consultation and Training

Pharma-EU can provide your company with the SOP for consultations with target user groups for PILs. Our SOP outlines timing of consultations as well as validated methodologies used for the procedure.

In-company training for PIL writing and revisions

We can provide specifically tailored training courses to help your company to cost effectively revise and write PILs to an acceptable format. The biggest problem we see with PILs today is they are written by medical professionals. A PIL is to be used by patient and needs to be formatted and written in a way patients understand. Our readability user testing experience has exemplified our PIL writing experience.

The experience of sitting with patients and asking questions about the PILs in over 200 user readability tests, has lead us to be able to write user friendly PILs. This experience can be shared.

SmPC Preparation

Summary of Product Characteristics can be prepared to help your product get to the market in a timely manner. Our medical professionals can help you achieve a SmPC ready for assessment.

Summary of Product Characteristics Comparison and Procurement

Pharma-EU s.r.o. can source, translate and compare SmPCs for MRP/DCPs from all EU countries and provide you with a core SmPC. A well prepared Summary of Product Characteristics will help your product get to the market the quickest.

Preparation of Clinical and Non-clinical Overviews

Our medical staff and chemists can prepare Clinical Overviews for your generic products at a very competitive rate and guaranteed to be accepted.

Non clinical overviews are prepared by a regulatory officer.