Pre-submission process:

•  Submission Strategy
• Preparation of Modules 1-5
• Choosing the most appropriate procedure type
• Managing all types of registration procedures for various products in the eCTD.
• Consultation on a legal basis and classification of products
• Handling registration procedures in all EU Member States
• Life-cycle management
• Dossier Compilation & Submission to Regulatory Authorities
  for Marketing Regulatory Submissions through:
  • National Procedures (NP)
    Mutual Recognition Procedures (MRP)
    Decentralized Procedures (DCP)
    Centralized Procedure (CP)