Requesting a Pre-assigned Application Number From CDER

Are you looking to submit your applications to the Food and Drug Administration? Aquila Solutions, your trusted pharma regulatory consultants, are here to guide you through the process. Our specialized pharmaceutical consulting services extend to FDA consulting to ensure your submissions meet all regulatory standards seamlessly.

A stamp that says FDA approved

The Procedure for Anything Being Submitted to the FDA

Navigating the FDA submission process can be complex, but fear not — Aquila Solutions is well-equipped to assist you every step of the way. Whether it's INDs, NDAs, ANDAs, or BLAs, our team of experts can streamline the submission procedure for you. By engaging with our FDA consulting services, you'll have a dedicated partner to facilitate a smooth submission process.

A pharma worker looking at a pill

A Pre-Assigned Application Number Can Ease the Process

Requesting a pre-assigned application number is a game-changer in simplifying your FDA submissions. Our pharmaceutical consulting experts at Aquila Solutions can help you obtain these numbers promptly, ensuring your applications are processed efficiently. With our assistance, you can navigate the regulatory landscape with confidence and ease.

Bottles of medicine

The FDA Has Introduced A New Process

Embracing innovation, the FDA has introduced a new process for requesting pre-assigned numbers via the CDER NextGen Portal. This modern approach offers enhanced user experience, automated confirmation, and historical record-keeping for all your requests. Aquila Solutions stays abreast of these developments, ensuring you benefit from the latest FDA submission procedures.

A factory worker posing for a photo

Aquila Solutions is Here to Help

At Aquila Solutions, we understand the significance of a streamlined submission process. As your trusted pharma regulatory consultants, we offer comprehensive FDA consulting services to simplify and expedite your submissions. By entrusting us with your regulatory needs, you can focus on core business activities while we handle the intricacies of FDA submissions efficiently.

Partnering with Aquila Solutions for your FDA submissions ensures a smooth and efficient process. Let us be your guide through the evolving regulatory landscape, providing tailored solutions to meet your specific needs. Reach out to us today and experience the difference our expert FDA consulting services can make in your submission journey.

Contact Us