We would like to advise you on exploiting your product to
its full potential:
Extend the period of data exclusivity, e.g. Paediatric
Use Marketing Authorisation (PUMA)
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 whole MA portfolio
to include:
• Variations
• Periodic Safety Update
Reports (PSUR)
• 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. (read
more here...)
Licensing in or out?
Due diligence is one of our specialities.
"Even
though timelines can sometimes be very tight, Cambridge Regulatory
Services has done their utmost to meet them. They have provided
timely responses to the regulatory authorities' questions
and shown flexibility… We are happy to recommend Cambridge
Regulatory Services to other companies who may need regulatory
help. They are a dedicated team who are always willing to
provide advice and support."
J.C.
Watson - formerly Andrex
Your Partner
of choice for a full Regulatory Service
Make
the most of a very valuable asset!
