eCTD Regulatory Publishing, Consulting & Strategy
At Aquila Solutions, we specialize in providing comprehensive regulatory solutions for small to medium pharmaceutical and biologic companies. With our deep understanding of the regulatory landscape and extensive experience navigating complex regulatory systems, we have successfully aided numerous clients in achieving regulatory compliance and bringing their products to market. We encourage you to explore our site to learn more about what we do, and discover why countless clients continue to choose us.
We offer an extensive array of services to help biopharmaceutical companies, clinical research organizations, and even other consulting firms fulfill their regulatory obligations. These include:
Navigating the requirements of electronic Common Technical Document (eCTD) submissions can be daunting. Our eCTD Regulatory Publishing services streamline the process, ensuring seamless compilation, formatting, and submission of regulatory documents. With our deep understanding of global regulations and utilization of industry-leading tools, we optimize your submissions for efficiency, accuracy, and compliance.
Accurate and standardized product labeling is essential for regulatory compliance. As such, our SPL (Structured Product Labeling) Authoring services enable clients to create and maintain compliant product labels. Our expert team ensures that labels align with regional requirements and facilitate effective communication with healthcare professionals and patients. Trust us to deliver high-quality, error-free labeling solutions.
Traversing regulatory landscapes can be complex and time-consuming. Fortunately, our Regulatory Consulting services provide you with the guidance and strategic insights needed to comply with regulations while optimizing your processes. Our experienced consultants stay up-to-date with evolving regulatory requirements, helping you develop effective market entry strategies and navigate the complexities of product development.
Collaboration, efficiency, and easy-to-use functionality come together in our Altair eCTD Viewer. Our intuitive software simplifies the management and access of electronic submissions, enabling efficient review, annotation, and navigation. With advanced search and security features, our viewer facilitates seamless communication with regulatory authorities, ensuring compliance and accelerating the approval process.
Aquila Solutions was founded in 2010 with the primary purpose of aiding small to medium pharmaceutical and biologic companies with navigating the regulatory systems. We have successfully published applications for biologics, sterile products, and combination products, among others.
Why Choose Aquila Solutions?
When you work with Aquila Solutions, you are partnering with a company that published over 2.5 million pages to the FDA in 2022 alone. Combine this fact with the following benefits we offer, and you can see what sets us apart as the ideal partner for your regulatory needs:
We prioritize accuracy in all our services. Our team of experts meticulously reviews and verifies all regulatory documents, ensuring a high level of accuracy and compliance. With Aquila Solutions, you can feel confident that your submissions and labeling will meet regulatory standards.
We understand the urgency of regulatory timelines. That is why we are committed to delivering fast turnaround times without compromising quality. Our streamlined processes, efficient workflows, and experienced personnel enable us to meet your deadlines, with over 80% of submissions being applicable for same-day/next-day delivery.
We believe in providing exceptional value at all times, offering highly competitive pricing without sacrificing on the quality and precision of our services. Our cost-effective solutions make regulatory compliance accessible to biopharmaceutical companies of all sizes.