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Sourcing Inquiry Logo DiaMed Beratungsgesellschaft für pharmazeutische Unternehmen mbH

DiaMed Beratungsgesellschaft für pharmazeutische Unternehmen mbH

Regions
Europe
Countries
Germany
Size
Specialty
Human Medicines
Service category
Consulting - strategy and development
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Key services

Services

 

Services

  • Advisory services related to Marketing Authorisation Applications (MAAs)
  • Evaluation and assessment of data relevant for MAAs
  • Literature/database search
  • Expert reports (CTD)
  • Preparation and Compilation of MAA dossiers
  • Full service on both the national and international level including official correspondence with Authorities
  • Compilation of CTD-Dossiers (also based on “NTA”-Dossiers); if requested also electronically
  • Preparation of QA-Documents, QA-related advisory services
  • Preparation of the applicants’ response to deficiency letters
  • PSUR: Database search and PSUR preparation
  • Graduated-plan officer, information manager (acc. to the German Drug Law)
  • Readability Tests of PIL

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