Preparation and submission of eCTDs and more

Electronic Common Technical Document (eCTD) preparation and submission are part of Beckloff’s broad range of regulatory publishing and content management services. While designed for eCTD, our system also efficiently supports printed output formats.

Who is it for?

Pharmaceutical, biotech, medical device companies and their partners with needs to submit to global regulatory agencies can take advantage of our services today. Use these services instead of or in advance of designing, building, testing and optimizing your own system.

What is provided?

Through our flexible outsourcing / service delivery model, you can take advantage of a full suite of service elements:

• conversion of source documents to pdf format,
• organization of content according to eCTD specifications,
• creation of efficient navigation (structures, bookmarks, hyperlinks),
• pre-submission quality and compliance assessment, technical and quality reviews

Features:

• 21 CFR Part 11 validated hardware/software system including robust publishing, electronic content management (ECM) and electronic labeling (SPL/PLR) components,
• professional, project-managed publishing process based on 32 years regulatory experience,
• templates (over 1000) and tools to ensure content and output quality, consistency and ease of navigation

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