Simplify EMA new drug approvals and maximise your savings with TMC
The EU is an attractive market opportunity for biotech or pharmaceutical companies looking to develop a new drug for a rare disease. However, obtaining EMA new drug approvals can be a complex and lengthy process, particularly for orphan drug designations.
You can significantly improve your chances of gaining market authorisation approval and secure substantial discounts on EMA fees with TMC’s regulatory submission services, which include acting as your marketing authorisation holder, if you don’t have a presence in Europe, to ensure compliance with all local regulations.
How can TMC support your regulatory submissions?
As a specialist, global clinical research organisation for rare disorders and diseases, we have extensive experience with all types of regulatory submissions in this area and can support you throughout the regulatory submission process.
From Phase 0 exploratory trials to Phase IV post-authorisation, we can help you:
- Secure orphan drug designations (ODD), including incentives such as fee reductions and market exclusivity.
- Ensure a smooth process for submitting paediatric investigation plans (PIP) and common technical documentation (CTD).
- Gain market authorisation (MA) approval efficiently and cost-effectively.
- Navigate post-approval regulatory affairs, including acting as your marketing authorisation holder (MAH) — taking on all legal and regulatory accountability to ensure your product is manufactured, marketed and distributed according to the terms and conditions laid out in the marketing authorisation.
TMC is here to help you through the regulatory submission process
Contact our team today at regulatory.services@tmcpharma.com or fill in the form to see how we can support you through the regulatory submission process and help you secure EMA new drug approvals efficiently and cost-effectively.