Regulatory

• New MAA and LifeCycle Management, National, MRP/DCP, Centralized Procedure
• EU & National Regulatory Requirements, Legislation Monitoring
• Artwork, Mockups, Multilingual packs
• CCDS, SmPC, PIL, Labelling full cycle
• High quality Swedish translations, QRD
• Medicines Database Maintenance (e.g. FASS, DKMAnet, Felleskatalogen)
• Review of Promotional Materials
• Module 2: Quality, Clinical, Nonclinical – Authoring
• Module 3, 4, 5
• CLP for chemical products and Safety Data Sheets

Pharmacovigilance

• Local and Global Literature monitoring
• Case Handling (ICSR)
• Periodic Safety Update Reports (PSUR)
• Risk Management Plan (RMP), additional risk minimization material (aRMM)
• Risk Assessments, DHCP
• XEVMPD, EVWEB
• Authoring & Review of SOP:s
• GVP Audits

QA Process

• QMS Set up
• SOP:s and Working Instructions
• Deviations & CAPA
• Change Controls

Interim

• Interim Team Management