SCIENCE SETS THE PACE. WE CLEAR THE PATH.
Bar charts. Gantt charts. Dependencies.
Scientists don’t hate project management. They hate being a bar on the Gantt.
Your Gantt chart tracks dates. It cannot see when one scientific setback will move your filing, your launch or your customer delivery. We can.
HYBRID PROJECT MANAGEMENT
Run the Marathon. Plan in Sprints. Decide at the Gates.
Hybrid project management for pharma: fast where the science moves, gated where decisions matter.
Plan in sprints
Short, evidence-led work cycles where the team controls the pace: development, dossier preparation, launch plans.
Decide at the gates
Go/no-go where investment or regulators require it. Fixed dates where time is fixed: stability, BE studies, agency responses.
See one view
Leadership sees progress and risk together, without status meetings.
WHAT THE GANTT CHART HIDES
The plan says on track. The science says otherwise.
| What the Gantt chart shows | What the scientist knows |
|---|---|
| Stability study 6 months, on track | If the 3-month data shows a trend, the shelf-life claim changes, and so does the filing. |
| Analytical method validation 4 weeks, on track | The method isn’t robust yet. Validate now and you validate twice. |
| API from second vendor Approved, delivered | The particle size is different. The formulation may not behave the same way. |
| Tech transfer to plant Week 12, complete | The plant setup differs from the pilot scale, and the process parameters are yet to be proven at scale. |
| BE study In progress | The reference product (RLD) batch expires before the study is completed. |
Illustrative scenarios, not client data.
Pharma Project Management challenges in API, Formulation and CDMO
Is this your challenge?
Each problem below starts as a scientific issue and ends as a missed deadline. Recognise even one? We have the solution.
Tech transfer delays during scale-up
The lab process is ready. The plant isn’t. Documents, equipment and trial batches sit with different teams and no one owns the transfer.
API timelines misaligned with the filing plan
Route, impurity work, DMF and supplier commitments run on separate plans. One slip quietly moves the formulation and the filing.
Formulation trials without decision gates
Trials, exhibit batches and stability starts move ahead with no clear go or no-go. Hard decisions get made late, and expensively.
Customer sample status not tracked
Samples are dispatched to the customer, but receipt, evaluation and feedback are recorded only in emails. Pending responses go unnoticed and the opportunity is lost.
Missed stability pull dates
Pull points tracked in a spreadsheet one person maintains. A missed pull surfaces only when the filing data is short.
Delayed R&D to Regulatory handoffs
Reports are done but not handed over. The dossier team waits, and nobody owns the gap between the two.
CDMO enquiries lost before contract
Enquiries sit between feasibility, quotation and contract with no single owner or follow-up date.
Hidden delays in outsourced studies
The plan says “in progress”. Approvals, enrolment and reports behind it are already late.
No consolidated launch readiness view
Each market has open items, but no one view shows what is outstanding and who acts next.
HOW WE FIX IT
1 · DIAGNOSE
Expose the silos
We map where functions work in isolation, duplicate effort and drop handoffs.
2 · DESIGN
Set owners, gates and rules
Decision gates, governance and escalation shaped around your pipeline.
3 · DIGITALISE
Make it visible and lasting
Trackers inside the tools your teams already use, plus adoption coaching.
Which of these is costing you time right now?
In 45 minutes, we map your workflow and show you exactly where the handoffs break. Led by practitioners with 24+ years in pharma project management.