Most launch plans I have seen start with a date.
Usually it is the date headquarters would like. The field force is hired against it, the congress is booked against it, and the forecast is built on it.
Then the registration takes the time it takes.
In my experience, the real launch date is set by four things, and only some of them are in our hands.
Dossier readiness. Is the file complete for this authority's requirements before it goes in? A missing document can cost more time than any review.
Authority queries. How fully and how quickly we answer. That part of the delay is ours.
Price approval. In the Gulf the authority sets the public price. Registration is not the finish line.
Listing and first stock. Formularies, import permits, the first shipment at the distributor. Only then can a patient get it.
So I plan the launch from the regulatory timeline, not from the global date. The tracker is reviewed every month with regulatory, medical, supply and marketing in the same room. And when a date moves, headquarters hears it from us early, with the reason.
It is a less exciting plan. It is also the one that does not leave a trained team waiting with nothing to sell.
“Your launch date is set by the approval, not by the plan.”
Lesson 7 of 17 in Step 4: Distributors and market access, with the full guide and a checklist for this week.