Biotech & Biologic: Post Approval: Cambridge Regulatory Services

	YOUR PARTNER for a full Regulatory Affairs Service

Home

Post-Approval Phase

Opportunities
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

YOUR PARTNER for a full Regulatory Affairs Service

Post-Approval Phase

No EU regulatory expert in-house?

Licensing in or out?

Broaden your market share with a Line Extension.

YOUR PARTNER
for a full Regulatory Affairs Service