Regulatory Publishing Services


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or at 913.451.3955.

Beckloff Associates has over 30 years of experience in preparing, reviewing and publishing regulatory submissions. Over these years, Beckloff Associates has expanded our services to include not only paper but also the electronic submissions. And now today, Beckloff Associates is considered an expert in the preparation and publishing of the electronic Common Technical Document (eCTD) submission. Our objective is to ensure the quality, consistency, and technical validity of the documentation, and to conform to the various regulatory requirements and quality standards. Routinely named as the U.S. Agent for maintenance of these regulatory files, Beckloff Associates works closely with our clients to provide the regulatory authorities with any additional chemistry and manufacturing information necessary for approval.

 

Regulatory Publishing Services:

  • Electronic and paper regulatory submissions and publications
  • Utilize 3rd party validated software to effectively and efficiently manage client submissions and publications
  • Creation of submission/publication outlines for organization of information
    • Outline components based on type of submission or publication
  • Conversion of source documents into electronically compliant PDF files
    • Managing source documents in an electronic document management system
    • Insertion of navigation aids (e.g., bookmarks and hyperlinks)
    • Scanning hard copies of source documents not available electronically
  • Electronic compilation of PDF files
    • Compliant electronic folder structure
    • Application of eCTD rules
    • QC review to ensure adherence to regulatory guidelines for eCTD
  • Compilation of Paper Submissions
    • Organization and preparation of tab identifiers according to regulatory guidelines for CTD
    • Organization and processing of source documents (e.g., pagination, formatting, etc.)
    • Assembly of requested number of paper copies
    • QC review for completeness
  • Consulting services
    • Provide guidance to clients and vendors on electronic submission guidelines
    • Evaluate document preparation processes and provide guidance for process improvements
    • Project management
    • Training seminar