Opportunities
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
Opportunities
