Submissions and Licence Maintenance
Our considerable “hands on” experience allows us to provide you with professional expertise across the full range of regulatory activities. We cover pharmaceutical, biological, generic and OTC medicines, medical devices and borderline substances including:- Applications for new drugs and line extensions (centralised, mutual recognition, decentralised and national)
- Preparation of CTD modules, overviews and summaries
- Preparation of e-CTD
- Dossier compilation
- Clinical trial applications
- Licence renewals and variations
- Legal status switches
- Summary of Product Characteristics, Patient Information Leaflet, labelling and prescribing information preparation and review
- Promotional material review and approval
- Management of merger-driven licence changes
- Adverse event reporting
- PSUR writing
- Orphan drug applications
- Free sales certificate applications
- Parallel import applications
- ACBS registration
- Wholesale Dealer Licenses
- Manufacturing and importation licence applications
- Site audits
