YOUR PARTNER
for a full Regulatory Affairs Service

Post-Approval Phase

Opportunities

Make the most of a very valuable asset!

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
• Help you manage ‘peaks’ in your regulatory workload (e.g. we can take care of your licence maintenance activities whilst important submissions are being made)

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.

CambReg have long established record of supporting clients post-approval….

"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."

"We have used Cambridge Regulatory Services to drive regulatory compliance and
to maintain a medicinal license, with great satisfaction. Cambridge demonstrated an admirable ability to take the lead, to drive regulatory strategy and to reflect the corresponding business objectives. Negotiation between various parties involved, as well as challenges associated with navigating through an old dossier and against timelines was managed with professionalism and confidence.

On a personal level, the team were very approachable at all times and access to their knowledge base was a real asset during the project. It was a pleasure to work with every member of the Cambreg team.

I look forward to working with Cambreg again in the future and will have full confidence in their ability to deliver quality and timely results."

K.D, Director Regulatory Affairs
Sciele Pharma