We have extensive experience of producing submissions to all major authorities worldwide. We cover North and South America, Europe (both centrally via EMA and individual competent authorities), major African countries, Australia, New Zealand, Japan, South Korea and beyond.
- Scientific advice procedures (EMA or national authorities)
We prepare briefing packages and participate at authority meetings, EMA, FDA, PMDA etc.
- Clinical trial applications (CTAs)
We review data, perform Gap Analyses and then prepare and submit applications for required countries. We also create and review investigational medicinal product dossiers (IMPDs)
- Mandatory provision of Legal Representative for clinical trials
When a clinical study sponsor does not have a local country office we accept to take the Legal Representative role in the countries that require it e.g. EU, Australia
- Orphan drug designations (ODDs)
We have written and submitted more than 150 successful ODD applications
- Paediatric Investigation Plans (PIP)
We have also written / negotiated more than 100 PIPs, this is a vital early step in the EU approval process
- Marketing authorisation approval dossiers (MAAs)
Either whole dossiers or specialist elements.
- European CTD overviews and CTD summaries
We produce CTD summaries and overviews for clinical, non-clinical and chemistry/pharmacy parts of the dossier, using external experts as needed during the process
- Support with product safety data evaluation and compilation of Risk Management Plans (RMP)
- Pre-approval sales authorisations
We have extensive experience of regulatory processes for compassionate/named patient use for niche products, orphan drugs and other special situations