Regresponse Ltd

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. Working in a timely manner, across multiple time zones, we are on time, every time. Common services we provide: Execution of strategic regulatory submission-related activities, including but not limited to: Scientific Advice/Protocol Assistance 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 and QC of each eCTD Module (1 – 5) for EU, US or other regions of the world Ad hoc scientific and strategic regulatory advice including interpretation of regulations, guidance, and requirements