Active Substance Master File (ASMF) Services:

ERA offers strategic counsel to optimise your ASMF submissions. We assess your specific situation and provide tailored recommendations to enhance the likelihood of approval.

Our experts stay updated with the latest regulatory changes and requirements, helping you stay ahead of compliance obligations.

Comprehensive Submission Management:

We will guide you through the entire ASMF submission process, ensuring all required documents and data are accurately prepared and submitted to regulatory authorities.

Our experienced team meticulously reviews and compiles the necessary information to meet regulatory expectations.

Timely Updates and Maintenance:

We monitor ASMF status and promptly update submissions, when required, to reflect changes in your active substance or regulatory guidelines.

Our proactive approach ensures that your ASMFs remain valid and up-to-date throughout the product lifecycle.

If you need any help with an ASMF or submission of ASMF updates as a MAH please contact us: