20/10/2021
To authorise its medicines in the different regulated markets (EU, EAEU, CIS, etc.) the pharmaceutical companies must prepare many documents, which are mostly time consuming.
However, there might often be a shortage of internal experts who could prepare such documents for those markets. Therefore outsourcing these tasks is often actually a good idea, because it will definitely help the applicant to do the planned submissions on time.
DUE Pharm team consists of highly skilled experts who are experienced in preparation of many country or territory specific regulatory documents, for example:
Module 1.3.1 - SmPC, Labeling and Package Leaflet
Module 1.3.4 - Consultation with Target Patient Groups (Readability User Testing & PIL Report preparation)
Module 1.6 - Environmental Risk Assessment (ERA)
Module 1.8.2 – Risk Management Plan (RMP)
Module 2.3 - Quality Overall Summary (from the source information received from the manufacturer)
Module 2.4 & 2.6 - Nonclinical Overview & Summary
Module 2.5 & 2.7 - Clinical Overview & Summary
Contact us to find out more information!
