We offer electronic publishing services in accordance with USA as well as international standards.
Most regulatory departments are staffed to handle normal submissions and responses. Few, however, are able to submit an initial application in a timely manner (A normal initial application requires one man year, or 2,000 hours.). Whether you utilize our U.S.-based personnel on an out-sourced or on-site basis, Aquila can submit most initial applications in weeks instead of many months and at a cost that is typically 20% below larger competitors.
Additionally, regardless of how you use us, we can bring personnel on-site for the final two weeks of large projects. This eliminates uploading and downloading data, phone calls and emails, simplifying the process and relieving stress.
In-Source Publishing Support Aquila provides on-site personnel to support your internal publishing team (see below for the type of people we provide). The client provides all systems and equipment and Aquila personnel follow your publishing workflows and standards.
Out-Source Publishing Support Aquila manages all publishing activities for the client (see below for the type of people we provide). The client provides finalized documents to Aquila and Aquila personnel use internal systems and equipment to deliver a submission ready eCTD. For small sequences (under 1,000 pages and 20 documents) Aquila will provide deliverables according to a standard timeline. For larger sequences Aquila assists as needed with the development of a submission plan and project milestones and will deliver completed documents according to the agreed upon timeline. This includes submission through Aquila’s FDA ESG account if requested.
Available Aquila personnel for on-site and out-source projects
Regulatory Publisher, Lead
The Lead Publisher is fully capable of planning and executing all publishing activities. This person can develop publishing plans, project management timelines and provide limited consulting advice on submission strategy. The Lead Publisher can work with all document types and is an expert with Adobe Standard and Microsoft Office and is also familiar with SAS transport and XML.
This person is capable of manually adjusting an XML backbone independent of a publishing system if required. This is the level of experience provided on-site for the final 2 weeks of a large out-sourcing project.
All sequences are approved by a Lead Publisher before they are ‘submission ready’.
Regulatory Publisher, Senior
The Senior Publisher is capable of fully publishing any sequence. This person can assess a publishing plan, identify common errors and create a compliant eCTD for any region. The Lead Publisher can work with all document types and is an expert with Adobe Standard, Microsoft Office and Insight Publisher as well as other publishing tools.
This person conducts a QC for Type 2 errors in all published documents.
Regulatory Publisher, Support
The Regulatory Publisher provide for document processing. This person reviews all finalized documents, cleans the documents and creates links and bookmarks as needed according to client standards and Aquila workflow. This person is very strong with Adobe Standard and Microsoft Office. They will be familiar with some publishing tools.
This person conducts a QC for Type 1 errors in all published documents.
Publishing Services Include
Project Management as Necessary
- Rolling document processing.
- Submission consulting
- Turn-around of 24 hours or less for most submissions.
- unreadable text,
- extraneous text like track changes,
- text format problems,
- a list of any document wide changes executed by Aquila, and
- any other concerns noted by Aquila.
Basic Review of Initial Documents:
- Conversion of all documents to PDF 1.4.
- Assess Scan quality.
- Page orientation.
- eCTD document granularity.
- Change page orientation as needed.
- De-skew scanned pages.
- Attempt to remove scanning artifacts like specs and lines.
- Shrinking contents to accommodate Headers and footers (as necessary and never more than 0.6 inches).
Bookmarking and Linking (B&L):
Aquila provides a Best Practices recommendation which can be customized based on individual client needs.
Headers and Footers:
- Custom headers and footers.
- Headers and footers applied to every PDF document except Cover Letters and Forms.
Document Quality Control (QC)
- 100% QC of every link and bookmark to ensure proper formatting and targeting.
- Review of every header and footer to ensure no header collision (Headers/Footers on top of document text).
- Sr. Publisher review of critical documents and verification of sequence.
- One submission review cycle.
- If the submission includes more than 15 final documents, a document review and a submission review cycle are included.
- Verification of eCTD structure.
- Verification of md5 checksums.
- Submission through Aquila FDA Gateway account.