Health Authorities Submission Gateways (FDA ESG, EMA CESP, PMDA gateway, etc.)

Regulatory Operations

eCTD Publishing and Submission Services

At Techsol Life Sciences, we ensure seamless delivery of regulatory dossiers to global health authorities through their respective electronic submission gateways with extensive experience in handling country-specific portal requirements, we manage the end-to-end submission process from final validation to successful upload and acknowledgment tracking.

What Sets Our eCTD Submission Services Apart?

Country-Specific Regulatory Compliance

We ensure each eCTD submission is designed according to the latest agency-specific guidelines, templates, and requirements. This includes:

FDA (United States): We manage IND, NDA, ANDA, and BLA submissions through the ESG portal, guaranteeing metadata accuracy, gateway envelope compliance, and proactive tracking of acknowledgment sequences (ACK 1, 2, and 3).
EMA and EU Member States: We facilitate MAA and variation filings via CESP under CP, DCP, MRP, or national routes.
Health Canada: We handle NDS, ANDS, CTA, SNDS, and NC filings via the Canadian ESG system.
PMDA (Japan): We expertly manage the Japanese eCTD format, including gateway configuration and lifecycle sequences.
TGA (Australia) and HSA (Singapore): We provide support for regional submissions in their evolving digital formats.

Secure Upload of Submission

Our trained submission coordinators:

Log into the appropriate portal
Upload the validated submission package
Complete required metadata fields and attach necessary cover letters or forms
Confirm successful file transmission

Acknowledgment (ACK) Tracking

After submission:

We monitor all system-generated acknowledgments (e.g., ACK 1, 2, and 3 from FDA ESG)
Track submission acceptance or errors from the authority’s end
Resolve any rejections or warnings promptly

All acknowledgment documents are archived and shared with the client for reference and audit readiness.

Archival and Documentation

We securely store:

Final submission package
Validation reports
Gateway upload confirmations and ACKs

Why Clients Choose Techsol Life Sciences

Challenges in Regulatory eCTD Services

Access credentials
File packaging formats
Acknowledgment interpretation and issue resolution

Techsol’s Regulatory Publishing Value Proposition

At Techsol Life Sciences, we deliver end-to-end regulatory publishing solutions that ensure accurate, compliant, and timely submissions to global health authorities. Our expert regulatory publishers guarantee precise eCTD formatting and consistency, leveraging in-depth knowledge of regional specifications including FDA, EMA, PMDA, and other global agencies. By utilizing industry-standard validation tools such as Lorenz Validator. We ensure error-free sequences and on-time submissions that drive successful approvals. Additionally, Techsol provides complete electronic gateway management, including setup, secure file uploads, and acknowledgment tracking, ensuring a seamless and reliable submission process from start to finish.