Dossier Management
Streamline Dossier Submissions and Responses
The Compliance Risk of Manual Document Management in Pharma
In the Pharma and Chemical industries, regulatory compliance hinges on timely and accurate document submissions.
Yet many organizations still rely on folders, shared drives, and email chains to manage critical documentation like ANDA files, Lab Development Reports (LDRs), and deficiency responses.
Dossier Management System
Missed deadlines, version confusion, and lack of traceability in interactions with global regulatory bodies.
PMSoft’s Dossier Management System is a centralized, workflow-driven platform designed to manage the full lifecycle of regulatory submissions and communications. It replaces fragmented document handling with structured digital workflows that support speed, compliance, and accountability.
With our Dossier Management module, you can:
- Digitally organize documents for ANDA, DMF, CTD submissions and more
- Manage Lab Development Reports and regulatory attachments with traceability
- Track submission status by country, region, or regulatory body
- Automatically route deficiency letters to relevant teams with action timelines
- Maintain structured Response Logs with document linkage and version control
- Implement Access Control, E-Signatures, & Audit Trails
- Enable Regulatory, QA, and R&D teams to collaborate in a unified workspace
- Generate dashboards for pending responses, recurring deficiency types, and compliance status
Tired of chasing documents when the deadline looms?
Contact us at : info@pmsoft.com
Built for the regulatory reality of global Pharma, PMSoft’s regulatory dossier solution combines industry regulations with modern IT practices. Our document management and management system approach helps clients move from manual document chaos to fully traceable, compliant workflows for product filings, country-specific variations, and regulatory submissions.
Our solution offers real-time tracking and visibility, reducing errors, improving response time to regulators, and ensuring a single source of truth across your documentation lifecycle. With an advanced document management framework and integrated regulatory dossier capabilities, PMSoft empowers teams to handle regulatory submissions efficiently and maintain compliance throughout every stage.
Why Choose PMSoft’s Dossier Management Module:
- Domain expertise
- Built-in templates, checklists, and review workflows
- Seamless integration with other project/digitalization modules
- Audit-ready compliance structure and retrieval system
FAQs
Questions Asked For Dossier Management
Do you still have any questions, let us know. We would be happy to assist.
Our system provides a centralized, version-controlled repository for regulatory documents—ensuring that ANDA filings, LDRs, and deficiency responses are submitted on time, with the correct versions, and with traceable approval workflows for audit-readiness.
No. This is a Custom Solution designed specific to customer’s requirements.
Absolutely. Each deficiency letter can be linked to responsible teams, with due dates, response logs, and attachments stored in one place. This ensures visibility and accountability in closing regulatory queries across functions.
