3 Common MHRA marketing authorisation challenges (and how to solve them)
Biotech and pharmaceutical companies face numerous challenges when commercialising [...]
Why you need a specialist for regulatory submissions in rare disease clinical trials
The path to regulatory approval for rare disease treatments [...]
A strategic guide to navigating your orphan drug designation application
Innovation is often the key to unlocking life-changing treatments [...]
What you need to know about marketing authorisation holder requirements in the UK/EU
In clinical research and drug development, regulatory submissions are [...]
Navigating the complexity of compliance review of UK/EU product communications for rare diseases
By Marcelo Vaz, Vice President of Medical Services at [...]
FDA orphan drug designation vs. EMA orphan drug designation
Orphan drug designation (ODD) is granted to drugs that [...]
How can marketing authorisation holders overcome these 5 post-approval regulatory affairs challenges?
Bringing a new drug to market doesn't end with [...]
TMC secures UK MAH for rare disease product in the United Kingdom
TMC, a global clinical research organisation (CRO) dedicated to [...]
What you need to know about different types of regulatory submissions
Regulatory submissions are essential for obtaining the necessary approvals [...]
Orphan drug designation criteria, benefits and the EMA new drug approval process
Treatments intended for rare diseases may not be profitable [...]