SPL Authoring

SPL Authoring

eCTD Publishing, SPL Authoring & More

Send a Submission (404) 496-4171

At Aquila Solutions, we are a team of trusted pharma regulatory consultants who specialize in guiding pharmaceutical companies through the complex world of structured product labeling (SPL). With years of experience and a deep understanding of FDA requirements, we are here to ensure that your SPL authoring process is smooth, compliant, and efficient.

Contact us today to learn more about our SPL authoring, eCTD publishing, and other regulatory consulting services. Let us help you bring your products to market quickly and efficiently while ensuring regulatory compliance.

Send a Submission

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What is Structured Product Labeling (SPL)?

Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by the FDA as a mechanism for exchanging product and facility information in an electronic format. SPL is used for the submission of drug establishment registration and drug listing information, as well as labeling information for human prescription drugs, biologics, and over-the-counter drugs.


Why is SPL Authoring Important?

SPL authoring is a critical step in the regulatory process for pharmaceutical companies. It involves creating the standardized document format required by the FDA for electronic submissions. SPL authoring ensures that pharmaceutical companies provide accurate and consistent information about their products, making it easier for healthcare providers and patients to access important information about the drugs they are prescribed.

At Aquila Solutions, we understand that SPL authoring can be a daunting and time-consuming task for pharmaceutical companies. That’s why we offer our expertise to assist you in the process, ensuring that your submissions meet FDA standards and are submitted on time.


Our SPL Authoring Services

At Aquila Solutions, we specialize in providing SPL authoring services for pharmaceutical companies navigating the complex world of regulatory compliance. With our team of experienced pharma regulatory consultants and FDA-structured product labeling specialists, we are here to streamline your SPL authoring process and ensure that your products meet the highest standards of quality and compliance including the following areas:

Drug Labels

  • Human Prescription
  • Human OTC
  • Bulk Ingredients
  • Cellular Therapy
  • Drug for Further Processing
  • Packaging Insert Creation


  • Establishment Registrations/De-Registrations
  • Labeler Code Activations & Inactivations
  • No-Change Notifications

Other SPLs

  • Dietary Supplements
  • Cosmetics

Why Choose Aquila Solutions for SPL Authoring?

At Aquila Solutions, we have years of experience working with pharmaceutical companies to ensure regulatory compliance and effective product submissions. Our team of experts is dedicated to providing top-quality services and achieving timely results for our clients. Here are some reasons to choose Aquila Solutions for your SPL authoring needs:

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Our team consists of experienced regulatory professionals with a deep understanding of FDA regulations and requirements for SPL submissions.

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Quality Control

We have a robust quality control process in place to ensure that all submissions meet FDA standards and are error-free.

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We understand the importance of meeting product launch deadlines and working efficiently to provide timely submissions.

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We value the confidentiality of our client’s information and have strict measures in place to protect their data.

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Customized Solutions

We recognize that every client has unique needs and we offer customized solutions tailored to their specific requirements.

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We stay updated with the latest FDA regulations and guidelines to ensure that all submissions are fully compliant.

Trust Aquila Solutions for Your SPL Authoring Needs

When it comes to SPL authoring, trust Aquila Solutions to provide you with the expertise and support you need. Our team of pharma regulatory consultants, FDA-structured product labeling specialists, and cutting-edge technology ensures that your SPLs are created efficiently, accurately, and compliantly. Let us simplify and streamline your SPL authoring process, allowing you to focus on what matters most — developing innovative pharmaceutical products and improving patient outcomes.

Take the first step toward ensuring compliance, patient safety, and maximum product usability with Aquila Solutions as your trusted partner in SPL authoring.

Get Started — Send a Submission