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Post-Approval Phase

Biotech & Biologic: Post ApprovalOpportunities
Make the most of a very 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 Certificate of Pharmaceutical Product (CPP)
  • Push the boundaries with your advertising material

 

Our Services

We can manage your whole MA portfolio to include:


• Variations
• Periodic Safety Update Reports (PSUR)
• Renewals

• Annual Safety Report (ASR)
• 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. (read more here...)

 

Licensing in or out?

Due diligence is one of our specialities.

 

Broaden your market share with a Line Extension.

 

"For those who require professional regulatory support and advice with the personal touch, I would not hesitate to recommend Cambridge Regulatory Services"

O.M.

Besins International

 

Your Partner of choice for a full Regulatory Service
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