Altair

Altair: eCTD Submission Management

Developed to revolutionize how pharmaceutical and biotech companies handle eCTD (electronic Common Technical Document) submissions, Altair helps sponsors through the regulatory process. With improved efficiency, accuracy, and compliance, the publishing tool is designed to make every aspect of eCTD publishing easier.

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Features of Altair

Regulatory professionals can benefit from all of these great features that make Altair an essential tool for eCTD publishing:

  • Multiple Views: Every perspective of your submission is available with Altair. With viewpoints like Application, Cumulative, Current, and Sequence, users can gain a full understanding of their eCTD submissions.

  • Integration: Navigate through all sub-folders and access detailed PDF documents directly within the viewer. This feature makes the review process easy and allows for eCTD FDA compliance.

  • Data Integrity: The viewer maintains the integrity of the data, ensuring all electronic common technical document submissions meet stringent regulatory standards.

  • Support for Regional DTDs: making it an essential tool for eCTD publishing across different regulatory environments.

Do You Need an Altair Subscription?

Managing complex data structures is a fundamental challenge in the regulatory landscape. Altair addresses this by providing a robust tool that simplifies eCTD submissions. It ensures accuracy, reduces the risk of errors, and improves the efficiency of the submission process. This necessity extends to maintaining compliance with evolving regulatory standards, which is crucial for the success of any regulatory strategy.

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Altair in the Pharmaceutical Industry

The pharmaceutical industry often deals with a high volume of standardized data that must be tracked and reported. The complexity and volume of data involved in pharmaceutical eCTD submissions require clear organization and a high degree of accuracy. The clarity of Altair’s multiple view options allow pharmaceutical companies to gather as many insights into their submissions as possible. This makes for easy collaboration among stakeholders.

Altair ensures that all submissions are accurate, reducing the risk of errors that could delay the approval process. Its ability to maintain data integrity and support various regional DTDs (including US and CA versions) makes it an invaluable tool for ensuring eCTD FDA compliance. By facilitating efficient and accurate submissions, Altair helps pharmaceutical companies bring their products to market swiftly and compliantly.

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Biotechnology Industry

The biotech industry often deals with cutting-edge therapies and treatments that require detailed and complex scientific data to be submitted to regulatory authorities. Altair’s integration feature allows biotech companies to navigate through all sub-folders and access detailed PDF documents directly within the viewer, making the review process straightforward and efficient.

Biotech submissions often involve novel data types and intricate scientific documentation. Altair supports the documentation of this complex data, ensuring it meets stringent regulatory guidelines. By providing a tool that simplifies eCTD submissions, Altair helps biotech companies focus on their core mission of innovation and development.

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Access Altair

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Free to Try

Includes:

  • All features of licensed version

  • 1 application with 10 sequences

  • Email support

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Annual Subscription

Includes:

  • Unlimited applications and sequences

  • All updates

  • Direct email and phone support

Partner With Aquil Solutions

With over a decade of experience in the pharmaceutical regulatory sector, Aquila Solutions has established itself as a trusted partner by pharmaceutical and biotech companies. When these companies need help preparing regulatory documents, they turn our way with eCTD templates.

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