I will support cmc, ectd and regulatory submissions globally

Need support with CMC documentation, eCTD publishing, or pharmaceutical regulatory submissions? I can assist with the preparation, organization, and publishing of regulatory documents for pharmaceutical products.

My experience includes working with US FDA requirements and supporting regulatory activities for US, EU, Japan, and Canada.

I can assist with:

• CMC / Module 3 document review & organization
• eCTD compilation and publishing
• eCTD sequence preparation
• Document formatting and PDF processing
• Regulatory documentation
• Amendments and post-approval activities
• Regulatory lifecycle management
• Technical documentation and scientific writing
• Document preparation based on provided requirements

I have a background in Chemistry and pharmaceutical regulatory affairs, with 2 years of hands-on experienceworking with small-molecule CMC documentation and eCTD publishing activities.

I focus on accurate document organization, technical consistency, and compliance with applicable requirements and client instructions.