Medical Innovation Exchange

IDMP

Preparing for a Data-first Regulatory World

Preparing for a Data-first Regulatory World     Even in today’s eCTD world, most life sciences regulatory teams still think and work in terms of documents, paragraphs and sentences when putting together collateral for marketing authorization and variations submissions. Yet it is data, rather than pre-prepared dossiers, that are moving into central focus now. Stakeholders across …

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A Single Source of Truth Helps Regulatory Teams

A Single Source of Truth Helps Regulatory Teams     Regulatory teams participate in every step of bringing a medical device or drug to market. Because of the essential role they play, these teams need advanced tools to keep pace with the latest regulatory bodies and standards. Legacy technology that siloes data across different pillars isn’t …

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