Our regulatory and medical writing expertise spans numerous therapeutic areas and regulatory path complexities. We also have expertise and experience with unconventional submissions, including expedited pathways, unclear precedence, and requests for re-examination. Common services we provide:
- Execution of strategic regulatory submission-related activities, including but not limited to:
-Scientific Advice/Protocol Assistance/Special Protocol Assessment (SPA)
-Clinical study protocols and reports
-EU and Rest of the World Clinical Trial Applications (CTA) and subsequent amendments
-US eCTD Investigational New Drug (IND)
-Briefing documents
-Paediatric Investigational Plans (PIP)
-Letter of Intent to Submit
-Eligibility Requests
-Regulatory Authority meetings (Scientific Advice, pIND, Pre-MAA, Pre-NDA, Rapporteur, and other agency meetings)
-Expedited programmes for serious conditions
-Orphan Drug Applications
-New Active Substance
-EMA MAA Re-assessment
- Preparation eCTD Modules 1 – 5 for EU, US, and other regions of the world
- Ad hoc scientific and strategic regulatory advice, including interpretation of regulations, guidance, and requirements
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