Services – Stenova

Compilation and formatting of regulatory dossiers in CTD/eCTD structure as per global authority guidelines.

Support for market authorization submissions, variations, renewals, and lifecycle regulatory documentation.

Preparation of scientific justifications and structured responses to regulatory authority deficiency letters.

Guidance for facility and quality documentation alignment with GMP and regulatory expectations.

Authoring of SmPCs, PILs, quality summaries, validation reports, protocols, and other regulatory documents.

Review and management of packaging artwork to ensure regional regulatory compliance and accuracy.

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