The diverse tasks in Regulatory Affairs include essential regularly duties like guarantee of tradability, the maintenance and further development of products and portfolio. At this PharmaExpert provide you best possible in life cycle management, variation and renewal application, demarcation and regulatory advice.
Medical Affairs: The medical part of marketing authorisation procedure needs the synopsis of pharmacology, pharmacovigilance and clinical management to establish preclinical, clinical and medicinal reports (CTD-Modul 2.4 bis CTD-Modul 2.7).
 

Overview about Regulatory Affairs activities:

• Life Cycle Management
• CTD
• Expert reports
• Variation applications
• Renewal applications
• Preparation of Summaries of Product Characteristics, Package Leaflets and Labeling