IDEA specialises in providing pharmaceutical and biotech developers with Regulatory Affairs and EU legal representation for clinical trials and orphan drug designations (ODD). We offer a range of Regulatory Affairs services to help our clients understand and comply with clinical trial regulations and help ensure a smooth path to Marketing Authorisation Approval.

Our clients include:

• Niche (orphan) drug developers looking to gain ODD in the USA and Europe
• Clinicians looking to ensure trial data is valid and appropriately covered
• Investors seeking to maximize the market opportunity of new molecules
• CRO’s who know the importance of determining suitable liability and trial subject insurance to cover human trials in Europe.

IDEA’s expert regulatory services range from the provision of stand-alone representative services for an Orphan Drug Designation (ODD) to the design and implementation of a full global regulatory and market access strategy. We are experts at the preparation and review of Regulatory Submissions, including Clinical Trial Authorisation applications and substantial amendments, Orphan Drug Designation applications to the EMA, and parallel submissions to the US FDA, Briefing Packages for Scientific Advice Procedures, Paediatric Investigation Plan (PIP) Applications and Waivers, and Annual Regulatory Reports.