Redefining regulatory submissions

Unleash regulatory efficiency with the next level of excellence.

Empower your regulatory success with α-eCTD

We specialize in cutting-edge eCTD software solutions, streamlining regulatory submissions for pharmaceutical and life science organizations. Our user-friendly platform enhances efficiency, accuracy, and compliance, empowering you to navigate the regulatory landscape with confidence.

FEATURES

Introducing our advanced α-eCTD software suite, meticulously designed to revolutionize regulatory submissions. Explore a plethora of cutting-edge features meticulously crafted to elevate your efficiency and ensure compliance.

Regulatory Intelligence

Web Interface for FDA Submission

Easy file organization:

α-eCTD helps you to organize your submission files into modules M1 to M5, as required by the FDA.

Comprehensive submission support:

α-eCTD supports a wide range of FDA submission types, including ANDA, Annual Report, and PADER.

Submission history tracking:

α-eCTD maintains a history of all your submissions for easy analysis and tracking.

FDA
Regulatory & Compliance Assistance

Regulatory Guidance

α-eCTD provides access to a variety of regulatory guidance documents from the FDA and ICH.

Compliance Checking:

α-eCTD can check your submissions for compliance with FDA regulations

Regulatory Intelligence:

α-eCTD can help you to review your submissions before submitting them to the FDA.

Reviews

α-eCTD for FDA Submission & Compliance

eCTD Submission

Web based system used for :-
Compile, Process, and Submit Applications for approval to the FDA.
Features include:

Arranging files in modules M1 to M5
Preparing submissions for ANDA, Annual Report, PADER, etc.
Maintaining a history of submissions for analysis.

Regulatory and Compliance Assistance

Helps to prepare and create submissions.
Acts as a guide for regulators in making validated and informed decisions based on data from ICH, FDA provided documents.
Data sources for RC Assistance include:

ICH provided material
FDA provided guideline and standard documents.

Benefits

Effective Submission

α-eCTD can help you to reduce the time and costs associated with FDA submissions by streamlining the submission process and automating many tasks.

Effective Accuracy

α-eCTD can help you to improve the accuracy of your FDA submissions by providing compliance checking and submission review features.

Compliance Assurance

α-eCTD can help you to reduce the risk of regulatory non-compliance by providing access to regulatory guidance documents and compliance checking features.