SPL and More
In addition to providing extensive eCTD publishing support we are also pleased to offer the full range of electronic publishing services.
SPL (Structured Product Labeling)
The FDA requires a variety of SPL documents for your products, facilities and company. Aquila can create these SPLs for you quickly and accurately. In addition we can maintain your registration and submit it through the Aquila ESG account if needed.
Aquila uses the current FDA standard systems and validation software to ensure fully compliant labeling. We also offer accelerated publishing if required.
There are no excel sheets or forms to fill out. Simply send us your label PDF and we will create your SPL quickly and cheaply!
Interested in a free training on SPL? Please visit our Complimentary Training – Using SPL (Structured Product Labels)
ACA 6004 (Drug Sample Reporting)
Beginning in October of 2012 the FDA began to require reporting of all drug samples distributed by a sponsor. Aquila can create your ACA 6004 submissions quickly and easily.
Aquila is fully capable of maintaining your ClinicalTrials.gov entries.
This will reduce the strain on your staff and allow you more time to manage your studies.
SAS Data Package Review
It is very common for bio-statisticians to conduct an excellent analysis of your clinical data but to present the actual data package in a non-compliant manner.
Aquila uses our experts to review the presentation of the data package to ensure that the data is presented correctly and can be readily reviewed by the FDA. We verify that the data sets are in the correct format, that the define file is accurate and that the annotated CRF is complete and fully integrated.
A data package that is not presented correctly can significantly delay the review and may result in the FDA requesting a re-submission.