Consulting
Regulatory Consulting
eCTD Publishing, SPL Authoring & More
Working with clients to speed up submissions.
Aquila Solutions has over 10 years of experience working with biologic and pharmaceutical companies as a consultant and publisher for their submissions to the FDA.
The Consulting Services we offer include, but are not limited to:
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Lifecycle Planning and Consultation
Our consulting team can aid clients in planning and managing the lifecycle and submission schedule of their applications from the beginning pre-IND meeting requests to the post marketing requirements of their products.
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eCTD Templates
With our combined 40 years of experience in eCTD Publishing, we have developed a set of templates that can be used to help accelerate your submissions. These guidelines are an excellent starting point for a new submission or a new sequence in a submission! For more information, please visit the Support page.
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Sequence Viewer Software
We have developed a proprietary eCTD viewer software, named “Altair,” which gives you a comprehensive overview of your entire submission, sequence by sequence, and has new features in development. For more information, please visit the Support page.
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Technical Assessments
Aquila allows clients to be confident in their new product purchases by offering a full lifecycle assessment of any existing applications. Also, Aquila offers technical assessments and validation of many sponsor software purchases currently on the market.
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eCTD Structure from FDA
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Sample eCTD Template