Redesigning Manual Dossier Workflows Into Scalable Regulatory Operations
Redesigning Manual Dossier Workflows Into Scalable Regulatory Operations
Redesigning Manual Dossier Workflows Into Scalable Regulatory Operations
About Project
About Project
About Project
Dossier is a regulatory platform used by pharmaceutical teams to prepare, compile, and submit approval-ready dossiers, coordinating inputs across QA, R&D, Clinical, and Manufacturing departments globally.
Over time, dossier preparation became inefficient due to manual handoffs, Unstructured documents, unclear ownership, and limited visibility, causing rework, delays, compliance risks, and dependency on emails.
Our goal was to simplify dossier workflows with a structured, guided system that improves clarity, reduces effort, ensures audit readiness, and enables faster, confident regulatory submissions.
Dossier is a regulatory platform used by pharmaceutical teams to prepare, compile, and submit approval-ready dossiers, coordinating inputs across QA, R&D, Clinical, and Manufacturing departments globally.
Over time, dossier preparation became inefficient due to manual handoffs, Unstructured documents, unclear ownership, and limited visibility, causing rework, delays, compliance risks, and dependency on emails.
Our goal was to simplify dossier workflows with a structured, guided system that improves clarity, reduces effort, ensures audit readiness, and enables faster, confident regulatory submissions.
About Project
Life Sciences
Team
Varun kashetty, S.Madhumala, Mallari Kishor
Subscription Category
Quick win
Project start Year
November 2025
Business Challenges
Business Challenges
Business Challenges
Delayed Dossier Completion Timelines
Delayed Dossier Completion Timelines
Delayed Dossier Completion Timelines
Manual coordination and unclear workflows prolonged dossier preparation, delaying approvals and slowing market entry across regions.
Manual coordination and unclear workflows prolonged dossier preparation, delaying approvals and slowing market entry across regions.
Manual coordination and unclear workflows prolonged dossier preparation, delaying approvals and slowing market entry across regions.
Inconsistent Regulatory Documentation
Inconsistent Regulatory Documentation
Inconsistent Regulatory Documentation
Inconsistent document versions and limited traceability increased regulatory risks, rework cycles, and inspection-related stress for teams.
Inconsistent document versions and limited traceability increased regulatory risks, rework cycles, and inspection-related stress for teams.
Inconsistent document versions and limited traceability increased regulatory risks, rework cycles, and inspection-related stress for teams.
Operational Inefficiency Across Teams
Operational Inefficiency Across Teams
Heavy reliance on emails and spreadsheets caused duplicated effort, higher training costs, and reduced cross-functional productivity.
Heavy reliance on emails and spreadsheets caused duplicated effort, higher training costs, and reduced cross-functional productivity.
Operational Inefficiency Across Teams
Heavy reliance on emails and spreadsheets caused duplicated effort, higher training costs, and reduced cross-functional productivity.
Our Approach
Our Approach
Our Approach
BMC
We used the Business Model Canvas to connect Deepforrest’s regulatory goals with dossier preparation workflows. It helped identify stakeholders, value drivers, and operational gaps.
These insights guided structured, compliant, and scalable dossier experiences across teams and markets.
BMC
We used the Business Model Canvas to connect Deepforrest’s regulatory goals with dossier preparation workflows. It helped identify stakeholders, value drivers, and operational gaps.
These insights guided structured, compliant, and scalable dossier experiences across teams and markets.
BMC
We used the Business Model Canvas to connect Deepforrest’s regulatory goals with dossier preparation workflows. It helped identify stakeholders, value drivers, and operational gaps.
These insights guided structured, compliant, and scalable dossier experiences across teams and markets.
RA Executive
RA Executive
RA Executive
Worked faster with guided workflows, templates, and AI assistance, reducing manual effort, duplication, and confusion during dossier preparation.
Worked faster with guided workflows, templates, and AI assistance, reducing manual effort, duplication, and confusion during dossier preparation.
Worked faster with guided workflows, templates, and AI assistance, reducing manual effort, duplication, and confusion during dossier preparation.
RA Head
RA Head
RA Head
Gained end-to-end visibility, clear ownership, and real-time progress tracking, enabling faster decisions, reduced bottlenecks, and predictable regulatory submissions.
Gained end-to-end visibility, clear ownership, and real-time progress tracking, enabling faster decisions, reduced bottlenecks, and predictable regulatory submissions.
Gained end-to-end visibility, clear ownership, and real-time progress tracking, enabling faster decisions, reduced bottlenecks, and predictable regulatory submissions.
QA
QA
QA
Ensured compliance through structured reviews, version control, and audit trails, reducing validation errors, rework, and last-minute approval risks.
Ensured compliance through structured reviews, version control, and audit trails, reducing validation errors, rework, and last-minute approval risks.
Ensured compliance through structured reviews, version control, and audit trails, reducing validation errors, rework, and last-minute approval risks.
Reviewer
Reviewer
Reviewer
Reviewed submissions efficiently using clear version comparisons, focused feedback tools, and controlled approvals, improving review accuracy and turnaround time.
Reviewed submissions efficiently using clear version comparisons, focused feedback tools, and controlled approvals, improving review accuracy and turnaround time.
Reviewed submissions efficiently using clear version comparisons, focused feedback tools, and controlled approvals, improving review accuracy and turnaround time.
Features & Improvements
Features & Improvements
Features & Improvements
Unified Dossier Control Dashboard
Unified Dossier Control Dashboard
Dashboard offers instant task status counts, dedicated AI assistance for dossier queries, and a centralized table displaying all dossiers by state, enabling faster prioritization, clearer visibility, and confident regulatory decision-making across teams.
Status Counts
Status Counts
AI Assistance
AI Assistance
Ownership Visibility
Ownership Visibility
AI-Powered Dossier Assistant
AI-Powered Dossier Assistant
AI assistance enables users to ask dossier questions, automate tasks, validate modules, generate summaries, translate content, and integrate tools within chat, reducing manual effort and improving regulatory decision speed across complex workflows.
AI assistance enables users to ask dossier questions, automate tasks, validate modules, generate summaries, translate content, and integrate tools within chat, reducing manual effort and improving regulatory decision speed across complex workflows.
Visuals
Visuals
Visuals
Business Impact
Business Impacts
Business Impacts
Less Training Time
Less Training Time
Standardized dossier templates and guided workflows reduced learning curves, minimized rework, and shortened onboarding time for regulatory users.
Standardized dossier templates and guided workflows reduced learning curves, minimized rework, and shortened onboarding time for regulatory users.
Standardized dossier templates and guided workflows reduced learning curves, minimized rework, and shortened onboarding time for regulatory users.
Faster Task Completion
Faster Task Completion
Clear module sequencing, status visibility, and AI assistance enabled faster compilation, accurate submissions, and timely dossier readiness globally.
Clear module sequencing, status visibility, and AI assistance enabled faster compilation, accurate submissions, and timely dossier readiness globally.
Clear module sequencing, status visibility, and AI assistance enabled faster compilation, accurate submissions, and timely dossier readiness globally.
Fewer Support Tickets
Fewer Support Tickets
Improved traceability, version control, and role clarity reduced regulatory queries, follow-ups, and support dependency during submissions and reviews.
Improved traceability, version control, and role clarity reduced regulatory queries, follow-ups, and support dependency during submissions and reviews.
Improved traceability, version control, and role clarity reduced regulatory queries, follow-ups, and support dependency during submissions and reviews.
Make your product the one users recommend!
Make your product the one users recommend!
Make your product the one users recommend!
