Liquent Regulatory Solutions for Life Sciences

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1. Outsourcing - Liquent Direct
2. Template Development
3. Legacy Conversions

i) Outsourcing

Liquent Direct
Through Liquent Direct, Liquent combines the power of the industry's leading regulatory publishing software with unparalleled regulatory and submission experience. Whether your organization is preparing one submission each year or multiple submissions, Liquent offers a true end-to-end solution. This includes:

• SPL label conversion
• eCTD submission publishing
• eCTD demos
• Legacy document scanning
• High-speed printing and all the critical steps in between.
• Consulting resources to your site
• Complete your submission at one of our Publishing Centers of Excellence in the United States or Europe.

Unparalled track record
Our Liquent Direct team has never missed a deadline and we have never experienced cost overruns. Here is just a sample of some of the submissions that we have completed:

• 132 volume eCTD to the FDA
• 300 volume paper CTD to the FDA
• 300 volume paper CTD to EU
• 3 Global CTDs (EU, CA, US)
• 3 eCTD demos to the FDA
• 3 eANDAs to the FDA
• 1,112 volume NDA to the FDA (one of the largest-ever NDAs)
• 150 volume NDA for pediatric indication of an existing drug
• 123 volume electronic BLA
• 100 volume and 300 volume NDA to Health Canada
• 100 volume CTD to Europe
• 78 volume, 150 volume, 300 volume eNDA to FDA
• 30 Marketing Authorization Applications, including a 540 volume MAA of over 3.6 million pages, 27 submissions to European, Australian and New Zealand authorities, and two eCTDs

At our publishing centers, we manage projects from beginning to end, whilst ensuring the security of all proprietary information.

Beyond offering publishing support during peak submission deadlines, using Liquent Direct services helps minimize the risk of "Refuse to File" notifications and ensures guidance-compliant submissions.

ii) Template Development

Part of the process of streamlining and standardizing publishing processes includes developing authoring and publishing templates. By their very nature, templates are customized to an organization's business specifications.

Liquent experts are available to assist you in creating Microsoft Word templates. During the business planning phase of the system implementation, a portfolio of custom templates can be identified, specific to your organization.

When new regulatory guidances are approved, we develop industry standard templates that are incorporated into our product suite.

Additionally, Liquent offers full eCTD Microsoft Word templates that meet ICH standards.

iii) Legacy Conversions

Preparing to convert your legacy information to electronic format? Let Liquent help.

Many organizations have tremendous amounts of information in electronic formats not ideally suited for maximum usage, as well as storage/archiving. Converting legacy information to electronic enables efficient reuse and repurposing of the content. The fidelity and integrity of the source information is maintained.