Welcome to SEQ Services, your partner in streamlining eCTD submissions for the authorization of medicinal products. Explore our expertise in meeting regulatory mandates for electronic submissions and lifecycle management.
Mandate Overview: Understand the mandate set by the Heads of Medicines Agencies (HMA) for European regulatory agencies to handle electronic-only eCTD submissions by the agreed end-2009 deadline.
Global Compliance: Learn about the mandatory eCTD format in key markets, including the European Medicines Agency and FDA CDER requirements since January 2010 and January 2008, respectively.
SEQ’s Expertise: SEQ assists in preparing submissions in eCTD and submitting them to relevant Regulatory Agencies. Tailored services cover Centralised (CP), Decentralised (DCP), and Mutual Recognition procedures (MRP), as well as National applications.
Lifecycle Management: SEQ’s services encompass the entire lifecycle, including initial applications, supplementary information, variations, renewals, and Periodic Safety Update Reports (PSURs).
Submission Management System: SEQ uses Lorenz DocuBridge as its Submission Management System, ensuring efficient eCTD and non-eCTD electronic submissions (NeeS).
Contact Us: For efficient eCTD submission solutions and expert guidance, contact SEQ at enquiries@nerin.co.im. Discover how SEQ simplifies the complex landscape of eCTD submissions.
