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Documentation Preparation and submission of Marketing Authorisation Applications Use of Centralised and Mutual Recognition procedures MHRA Parallel Import Product Licences EMEA Parallel Distribution Notifications Drug Master Files and European Certificates of Suitability Export certificates Clinical Trial Applications Applications for other types of licences, such as Wholesale Dealer's Licence and Manufacturer's Licence Post-licensing documentation such as Variations, Renewals, Labels and Leaflets Conversion of dossiers into Common Technical Documents Consultancy - Advice on regulatory requirements and strategy
- Due diligence of regulatory data for submission
- Arranging and accompanying clients to meeting with the authorities, such as MHRA & EMEA
- Seeking in/out licensing opportunities regulatory consultancy
- Ad hoc
Support services Management of regulatory projects as determined by clients Translations Literature Searches
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