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 [...]
Understanding the role of a marketing authorisation holder in the regulatory submission process
In clinical research and drug development, regulatory submissions are [...]
TMC appointed UK marketing authorisation holder to drive rapid commercialisation of rare disease drug
TMC, a global clinical research organisation (CRO) dedicated to [...]