Whether for one aspect of a project or complete support from inception to approval, we can help with:

• Strategic planning from design to market for global markets.
• CTD/eCTD preparation and submission for new drugs, generic drugs and clinical trials.
• CTD/eCTD compatibility formatting across global regions.
• Representation/Official correspondent to governing regulatory bodies (FDA/TPD/EMEA).
• Drug Master File preparation and submission.
• Risk management (warning letters, consent decree representation, recall strategies).
• Labeling and advertising preparation and review.
• Phase I-III meetings
• Trial study initiation and monitoring

• Quality systems design and auditing
  
• Inspection readiness and coordination
  
• Corrective action planning  
• Vendor audits
• SOPs, documentation and implementation