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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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For more information email us at info@pharexcelconsulting.com or contact us today.
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