DRUGS REGULATORY SERVICES

Adore Research provide wide range of services for drugs regulations including:

• Advice and strategy for European, Canada and FDA submission procedures

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• Lifecycle development planning

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• Regulatory gap analysis & due diligence

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• Scientific advice, expert oversight and review of data

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• Follow-up strategies and action

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• CTD preparation of modules, overviews and summaries- electronic submissions prepared in the eCTD, NeeS, VNeeS and other electronic dossier formats

 

• ASMF preparations for centralized, decentralized, mutual Recognition and national procedures