Requirements

Please check off the appropriate qualification and experience levels that correspond with your resource requirement.

Column 1
  1. General Regulatory Experience
  3. Human Medicine
  5. Veterinary Medicine
  7. European Procedures
  9. US Procedures
  11. Other International Market Procedures
  13. Ethical Pharmaceuticals
  15. Biotechnology
  17. Generics Industry
  19. Compliance
  21. Pharmacovigilance
  23. Leaflets & Labeling
  25. Qualified Person Status
Column 2
  1. Preparation for Manufacturing Site Audit
  3. Clinical Trial Applications
  5. New Product License Applications
  7. Abridged Applications
  9. POM to P Switching
  11. Medical Writing
  13. Expert Reports
  15. Dossier Preparation
  17. CTD Module 1
  19. CTD Module 2
  21. CTD Module 3
  23. CTD Module 4
Column 3
  1. CTD Module 5
  3. Product License Renewals
  5. Product License Changes (Variations etc)
  7. Summary of Product Characteristics Writing
  9. Patient Information Leaflet (PIL) preparation
  11. PIL Readability Testing
  13. Over-the-Counter (OTC) Medicines
  15. Nutritional
  17. Herbals
  19. Drug Master Files
  21. Filing Strategy
 

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