eCTD Regulatory Publishing

eCTD Regulatory Publishing

Aquila Solutions is proud to be your trusted partner in eCTD regulatory publishing. With over 40 years of combined experience, we excel at aiding small to medium pharmaceutical and biologic companies in navigating the world’s complex regulatory systems. Our commitment to accuracy, flexibility, and fast turnaround times sets us apart in the industry, all of which can be evidenced in our eCTD regulatory publishing solutions. Continue reading below to learn more about our offerings, then contact us to get started.

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What Is eCTD Regulatory Publishing?

eCTD (electronic Common Technical Document) regulatory publishing is the process of preparing and submitting electronic regulatory submissions to health authorities, such as the FDA, EMA, or Health Canada. It replaces the traditional paper-based submission process, providing a standardized format that ensures consistency and efficiency in the regulatory review process.

Our eCTD Regulatory Publishing Services

At Aquila Solutions, we offer a comprehensive suite of eCTD regulatory publishing services to meet the diverse needs of our clients. Our experienced team is well-versed in handling various types of submissions, including INDs, NDAs, DMFs, and BLAs. Some of the services we provide include:

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eCTD Preparation:

Our publishing staff creates the XML backbones for eCTD submissions, ensuring compliance with both DTD 2.01 and 3.3. We meticulously organize and structure the submission documents, resulting in seamless navigation for health authorities during the review process.

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Regulatory Consulting and Strategy:

Our experts provide guidance and strategic advice throughout the regulatory submission process. We stay up-to-date with the latest regulations and guidelines, ensuring compliance and maximizing your chances of success.

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Project Management:

Our dedicated project managers work closely with you to oversee the entire eCTD publishing process. From timeline management to document tracking, we follow a smooth and efficient submission process.

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SPL Authoring:

We assist in the preparation and formatting of labels and packaging materials, ensuring compliance with regulatory requirements. Our detailed approach ensures accuracy and adherence to industry standards.

What Our Process Looks Like

Our streamlined process simplifies the eCTD regulatory publishing journey, enabling you to focus on your core business activities. Here's a glimpse into our process:

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Initial Consultation:

We begin with an initial consultation to understand your specific requirements and timelines. This helps us tailor our services to meet your unique needs.

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Document Preparation:

Our in-house staff prepares your submission documents, ensuring they are submission-ready. We carefully review and proofread the documents for accuracy and completeness.

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eCTD Publishing:

Our publishing team creates the XML backbone for your eCTD submission, following the required format and structure. We make sure all documents are properly linked and indexed for easy navigation.

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Quality Assurance:

We perform rigorous quality checks to ensure compliance with regulatory standards. Our attention to detail means that your submission will meet the highest quality standards.

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Submission and Tracking:

We submit your eCTD dossier to the relevant health authorities and track its progress throughout the review process. We promptly address any queries or requests for additional information.

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The Benefits of Partnering With Aquila Solutions

Partnering with Aquila Solutions brings several benefits to your biopharmaceutical organization. First and foremost, our team of regulatory publishing experts brings expertise and experience to navigate the regulatory landscape successfully. We prioritize accuracy and compliance, ensuring error-free submissions that meet all regulatory requirements.

Additionally, our efficient processes and dedicated team enable us to provide same-day or next-day turnaround for most submissions. By choosing Aquila Solutions, you can have peace of mind knowing your eCTD regulatory publishing needs are in timely hands, allowing you to worry less about deadlines.

In the ever-evolving pharmaceutical and biologic industry, navigating the regulatory landscape can be an intimidating task. However, Aquila Solutions is here to simplify the eCTD regulatory publishing process for you.

Our comprehensive services, streamlined process, and commitment to accuracy and compliance ensure a smooth submission journey. Contact us today to learn more about how we can assist you with your eCTD regulatory publishing needs. Together, let's accelerate your path to regulatory approval.

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