Regulatory services:

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• 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.

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• ASMF preparations for centralised, decentralized, mutual Recognition and national procedures.

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• Annual updates and amendments for US, Europe (CEP & ASMF), WHO and Canada.

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