An Initiative of Emona Biopharma and KI Pharma Alliance

Your EU Marketing Authorisation Deserves to Live.

We don't just help you register your pharmaceutical products in the EU. We place them on the market, protect your MA from the sunset clause, and connect you with commercial partners.

Most companies get approved.
Then nothing happens.

Regulatory consultancies help you get the marketing authorisation, then walk away. Without anyone to actually place the product on the EU market, your investment evaporates.

⚠ EU Regulation (EC) No 726/2004

The Sunset Clause

A marketing authorisation automatically expires if the product is not placed on the market within 3 years of approval, or if removed from the market for 3 consecutive years. No exceptions. No extensions. Your entire regulatory investment, gone.

💸

Investment Lost

Years of dossier preparation, agency engagement, and regulatory fees, completely wasted.

Clock Ticking

From the day your MA is granted, you have exactly 3 years. Most companies don't realise until it's too late.

🔒

No Second Chance

Re-registration means starting over. New submissions, new fees, new timelines. If you can even justify it.

Registration. Placement.
Protection. Support.

Better Rx is the only partner that takes you from regulatory strategy to packs on the EU market, and beyond.

📋

Regulatory

We build your EU regulatory strategy and prepare your dossier for submission via the optimal procedure: Centralised, Decentralised, or Mutual Recognition.

  • CTD dossier compilation (Modules 1–5)
  • Agency engagement & scientific advice
  • EU GMP certification triggering
  • Lifecycle management & renewals
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Market Placement

The critical step others miss. We physically place your product packs on the EU market, the single action that stops the sunset clause clock.

  • Pack placement on EU market
  • Import authorisation & batch release
  • EU GDP-compliant distribution
  • Pharmacovigilance setup (QPPV)
🤝

Commercial Support

Beyond placement, we help you find routes to revenue through strategic consulting and access to our established EU partner networks.

  • Partner network introductions
  • Go-to-market consulting
  • Tender & formulary strategy
  • Market intelligence & reporting

Traditional consultancy
vs. Better Rx

Capability
Traditional
Better Rx
Regulatory dossier (CTD)
MA submission & approval
EU GMP certification support
Market placement (sunset protection)
Pharmacovigilance (QPPV)
Commercialisation consulting
Partner network access
Tender strategy support

Flexible partnership models

Most Popular

Full Service

End-to-end protection

We handle everything: regulatory submission, EU GMP, market placement, and sunset protection. You supply the product, we secure your EU presence and explore commercial opportunities.

Protect & Place

MA + market placement

We manage your regulatory pathway and place packs on the EU market to stop the sunset clock. You take it from there, or use our commercial consulting and partner network.

Urgent

Rescue Track

Already approved?

You have the MA but no market presence. We fast-track placement, distribution, and pharmacovigilance setup to get your product on market before the sunset deadline.

Your future in the EU
with us

Your marketing authorisation is an asset. Let's make sure it stays alive and starts working for you.