Consulting

Regulatory Consulting

eCTD Publishing, SPL Authoring & More

Send a Submission (404) 496-4171

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

Ready to get started?