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Post-Approval Phase

NCE: Post ApprovalOpportunities
Make the most of a very valuable asset!
We would like to advise you on exploiting your product to its full potential:

  • Prepare for an indication extension
  • Learn how to protect from parallel imports
  • Increase the number of markets with a Certificate of Pharmaceutical Product (CPP)
  • Increase market share by legal entity change, e.g. Prescription to OTC
  • Push the boundaries with your advertising material

Our Services

We can manage your 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 specialties.


Start the regulatory process over again with a Line Extension?

Your Partner of choice for a full Regulatory Service

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