Strategic Support Across Regulatory Milestones
Aurora Insights offers strategic and hands-on support across key regulatory milestones, including:
Orphan Drug Designation (ODD)
End-to-end support from eligibility assessment and submission to status maintenance at marketing authorisation. Aurora Insights can prepare and submit ODD requests, enabling access to EU orphan incentives for companies based outside of the EU.
Paediatric Investigation Plans (PIPs)
Strategic planning, authoring, and EMA engagement. Support includes initial PIP development, modifications, and compliance strategy aligned with product lifecycle and regulatory expectations.
Scientific Advice / Protocol Assistance
Preparation, peer review, and meeting coordination. Aurora Insights helps shape questions, draft briefing documents, and guide sponsor interactions with EMA and national agencies.
Priority Medicines (PRIME) Designation
Eligibility assessment, submission strategy, and ongoing regulatory dialogue. Support includes evaluating readiness, drafting the request, and aligning with EMA’s innovation framework.
Small and Medium Enterprise (SME) Status Applications
Initial applications and renewals with full documentation support. Aurora Insights holds EMA SME status and can submit SME requests and hold SME status for non-EU companies that meet the criteria, enabling access to EU SME incentives.
Investor-Facing Regulatory Support
Independent evaluations of regulatory strategy, timelines, and risk. Aurora Insights supports investor due diligence, asset positioning, and strategic planning across the development lifecycle.