YOUR PARTNER
for a full Regulatory Affairs Service

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Post-Approval

Post-ApprovalOpportunities

Make the most of a valuable asset!

  • We can advise you on exploiting your product to its full potential:
  • Prepare for an indication extension
  • Consider how to protect your market share from parallel imports
  • Increase the number of markets with a CPP
  • Push the boundaries with your advertising material

 

Our Services:

We can manage your whole MA portfolio to include:

• Variations
• Periodic Safety Update Reports
• Renewals
• Change of Ownership
• Pricing and reimbursement
• Vetting of advertising materials

No EU regulatory expert in house?

We can maintain your MA portfolio until you have reached a size where it becomes essential to have your own in house regulatory staff

Licensing in or out? Due diligence is one of our specialities

Broaden your market share with Line Extensions.




”For those who require professional regulatory support and advice with the personal touch, I would not hesitate to recommend Cambridge Regulatory Services” (OM - Besins International).

Your Partner of choice for a full Regulatory Service
 
 
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