At Agilix, we support organizations through every step of the submission preparation and management process, ensuring that all regulatory requirements are met and submissions are completed efficiently.

Here’s how we help:

Initial Assessment and Strategy Development: We begin by assessing your product and regulatory requirements to develop a tailored submission strategy. This ensures that your submission is aligned with the specific expectations of the relevant health authorities.

Regulatory Review and Compliance Check: We conduct thorough reviews of all submission documents to identify any gaps or compliance issues. This step helps prevent delays and increases the likelihood of a successful submission.

Electronic Submission Formatting: We format your submission documents according to the required electronic standards (eCTD or other formats), ensuring they meet the technical specifications of health authorities.

Submission Management: Our team handles the submission process from start to finish, including coordinating with health authorities, tracking submission status, and managing timelines to ensure timely delivery.

Post-Submission Support: After submission, we provide ongoing support to address any questions or additional requirements from health authorities. We also manage responses to regulatory queries and help with any follow-up submissions and final approval.

With Agilix as your partner, you can be confident that your submission will be meticulously prepared to meet regulatory authority requirements, streamlining your product registration and facilitating a successful market entry.

Our services include:

• Submission of Full Applications (NDA, ANDA, NDS, ANDS and MAA etc)

• End-to-End Product Registration

• Market Extension Dossiers

• End-to-End DMF Registration (DMF, ASMF, CEP etc)