Example: Checklist "GDOP" - Global Development Operational Plan

DD-CRITERIA with specific focus on the GDOP = Global Development Plan of a NCE or Biological product. Overall, more than 150 key parameters/quality drivers of a valid GDOP process can be assesses by our specific DD procedures.

Overview of the 5 corresponding Key Areas:

A. Project [Product]

  1. SmPC [SUMMARY OF PRODUCT CHARACTERISTICS] - Product Profil
  2. Targeted Labeling
  3. Product Development Criteria & Development Highlights

B. Development Process

  1. Pre-clinical Status and Plans
  2. Key Clinical Study Results Summary
  3. Ongoing and Planned Clinical Trials

C. Regulatory

  1. Key Regulatory Contacts and Implications (FDA, EMA, Pharmaceuticals and Medical Devices Agency Japan, [PMDA]

D. Manufacturing / IP / Patents

  1. Key CM&C Status and Plans
  2. Key Patent Status / IP and Market Exclusivity

E. Project Management

  1. Key Operational Issues
  2. IT-Technology & Actions
  3. Development Investment Overview
  4. Quarterly updated and revised Action Plan (1 Year, 2 Years, 3 Years and Projection 5 Years)
  5. Long-Term GDOP Key Event Map