Beyond the Gantt chart: what one deficiency letter taught us about pharma leadership
CASE STUDY 03 · REGULATORY QUERY MANAGEMENT
Formulations company, Pune, India · 2019 · Area: agency query responses across functions
What leadership gained: one view of every open question, its owner and its due date, without access to confidential documents.
The brief, and the request that changed it
In 2019, we were designing a project management solution for a Pune-based formulations company. The brief was familiar: plans, milestones and a portfolio view for leadership.
Midway through, the client asked a different question: “Can you suggest a solution for our agency queries?”
A deficiency letter with fourteen questions had just arrived. Each question was sent by email to the function that held the data: QC, QA, formulation R&D, packaging and the API supplier. By day 60, six were answered. The company requested an extension, then submitted incomplete answers with commitments to meet the deadline. The regulator raised a second round of questions.
What we found
Every function had done its work. The RA team had done everything asked of it. The delay came from three gaps in management, not in science.
- No owner for each question. The letter had one owner in RA. The fourteen answers had none.
- No shared view. The company had a document management system, but access was restricted for security reasons. Many respondents, including plant teams, the packaging vendor and the API supplier, could not see it. Status existed only in email.
- Meetings as the only status tool. Senior people spent hours in weekly meetings asking one question: “Where is it?”
What we built
We introduced a single management register: every question listed separately, with its function, owner, internal due date and status, visible to everyone who had to answer.
The register held no confidential documents. Those remained in the document management system, under its access controls. It held only the management layer: who owns each answer, what is pending, and by when.
The weekly meeting changed purpose. Instead of collecting status, it reviewed only the items that were overdue or at risk, and it took a fraction of the time.
What we learned beyond project management
The project plan got the product to the filing. After that, leadership’s questions were about the regulator, not the plan: which queries are open, which filing is at risk, and when the product can launch.
Project management remained the foundation. It still determined whether the work was planned, resourced and sequenced. What leadership needed beyond it was a clear view of the work that a plan cannot show.
Three lessons have shaped everything we have built since:
- Leadership measures outcomes, not tasks. A CXO asks about filings, approvals and launches. A plan full of completed tasks does not answer that question.
- The critical work lies between functions, and outside the project plan. Queries, samples, stability pulls and supplier responses pass from one team to another. No Gantt chart shows who holds them at any moment.
- Status must be visible without opening confidential documents. Everyone who contributes to an answer needs to see what is pending and by when. Very few of them need access to the dossier.
This is the approach our RA Tracker is built on, and later our Launch Tracker. Both run inside the customer’s existing Microsoft 365 and complement the document management system.
Today we offer both: project management for the plan, and trackers for what the plan cannot show.
Could this be your organisation?
Answer yes or no:
- Can you state today how many agency queries are open, across all markets?
- Does each question have a named owner in the function that holds the data?
- Can every respondent, including your suppliers, see the status without access to your document management system?
Each “no” marks a point where a response can lose weeks.
In 45 minutes, we map your query response workflow and show you where responses lose time. No generic demo. No obligation.