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About Aquila

Aquila provides Electronic Regulatory Publishing Services for initial applications, including eCTD (INDs, (A) NDAs, BLAs, MAAs, DMFs and others), SPL, ClinicalTrials.gov submissions and SAS Data Package reviews.  We also provide a full range of consulting and services for long-term lifecycle management. We are full-service U.S.-based Electronic Publishing resource for small and medium sized Pharmaceutical and Biologics companies, having successfully published applications for biologics, sterile products and combination products. All major sequences have been submitted on time. Read More
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Application Publishing

Aquila provides on-site and U.S. based out-sourced personnel required to deliver a submission-ready eCTD. Read More

Labeling and More

Aquila can address all your electronic regulatory publishing needs including SPL generation for devices as well a biologics. Read More

Submissions Consulting

Aquila works closely with clients during the lifecycle and backbone planning process to eliminate rework hours and technical errors. Read More

RegOps Consulting

We can help you develop a RegOps department that optimizes document control and archiving, freeing your managers and directors for higher-level activities. Read More

What Clients Say

"I was surprised to discover that an initial application takes up to 2,000 man-hours to publish but Aquila helped us finalize our application in months instead of a year!" - Director of Regulatory

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