Publishing Services

Publishing Services

eCTD Publishing, SPL Authoring & More

Send a Submission (404) 496-4171

At Aquila Solutions, we recognize the critical role that efficient and accurate publishing plays in the complex world of regulatory compliance. With our comprehensive publishing services tailored specifically for small to medium pharmaceutical and biologic companies, we ensure that your regulatory submissions are of the highest quality and compliant with global regulations. Our expertise in electronic Common Technical Document (eCTD) publishing, SPL authoring, and document editing is simply second to none.

Img.png

eCTD Publishing

With Aquila Solutions by your side, you no longer have to navigate the intricacies of eCTD submissions alone. Our eCTD publishing services streamline the process from beginning to end, ensuring that your regulatory documents are compiled, formatted, and submitted in compliance with global regulatory requirements. Our experienced team utilizes industry-leading tools and techniques to optimize your eCTD submissions, facilitating a faster approval process and minimizing delays.

From the compilation and organization of documents to the creation of XML files for INDs, NDAs, DMFs, and BLAs, we provide end-to-end support throughout the publishing process. Trust Aquila Solutions to handle the complexities of eCTD publishing, allowing you to focus on other critical aspects of your business.

SPL Authoring

Our SPL authoring services enable you to create and maintain compliant and comprehensive structured product labels. Our expert team ensures that your labels meet regional requirements and provide clear information to healthcare professionals and patients. We leverage our deep understanding of regulatory guidelines and industry standards to develop error-free SPLs that effectively communicate essential information about your products.

Whether you need drug labels, establishment registrations, labeler code requests, or even no-change notifications, Aquila Solutions is here to streamline your SPL authoring process and ensure compliance with regulatory authorities.

Document Editing

Effective document editing is essential to ensure clarity, consistency, and compliance in your regulatory submissions. Our skilled team of editors meticulously reviews your documents, removing any errors, improving readability, and ensuring adherence to regulatory guidelines. We pay close attention to detail, scrutinizing every aspect of your documents, including formatting, grammar, syntax, and terminology.

With Aquila Solutions, you can confidently submit professionally edited documents that present your company and products in the best light. Our document editing services go beyond mere correction; we enhance the overall coherence and flow of your content, making your submissions concise, accurate, and highly effective. And rest assured, we track and communicate all changes so you still have the final say.

Publishing Solutions Designed for Your Business

At Aquila Solutions, we understand that each pharmaceutical and biologic company has unique publishing needs, and a one-size-fits-all approach simply won't do. That's why we offer personalized and tailored solutions designed specifically for your business. Whether you need end-to-end eCTD publishing services, targeted support for SPL authoring, or expert document editing, we have the expertise and flexibility to meet your needs effectively.

Our team collaborates closely with you, taking the time to understand your goals, challenges, and specific submission requirements. With this personalized approach, we deliver solutions that seamlessly integrate into your regulatory processes, saving you time, effort, and resources.

Get ready to streamline your publishing processes and optimize your regulatory submissions with Aquila Solutions. Together, we can simplify your publishing needs, ensuring your submissions meet the highest standards and gain the approvals you need to bring your products to market.

Contact us today to discuss your publishing requirements in more detail and discover how Aquila Solutions can assist your organization.

Ready to get started?