in stranded SKUs identified
"They identified $38M in stranded SKUs we'd been carrying for four years. The analysis was done in six weeks. We had the board memo drafted before the quarter closed."
VP, Regulatory Affairs & Portfolio Strategy
Top-20 US Specialty Pharma
Prescribe advises mid-cap pharmaceutical companies on FDA submissions, portfolio rationalization, and post-merger integration — the engagements where a misread guidance document costs eighteen months and forty million dollars.
Engagements with companies including
140+
FDA submissions managed
23
Portfolio rationalizations
$2.1B
In portfolio value assessed
Traditional Portfolio Review
vs. Prescribe Rationalization Framework
Most portfolio rationalization efforts stall because they treat product discontinuation as a commercial decision. It isn't. It's a regulatory event with commercial implications.
| Dimension | Traditional Review | Prescribe Framework |
|---|---|---|
| Scope definition | Revenue-based cutoffs applied uniformly across the portfolio | Lifecycle-stage weighting combined with regulatory liability mapping per SKU |
| Data inputs | Finance and commercial data only; regulatory costs estimated | Regulatory burden, CGMP compliance status, and supply chain concentration risk integrated at SKU level |
| Decision timeline | 9–14 months from kickoff to board recommendation | 6–8 weeks to prioritized discontinuation list with defensible documentation |
| FDA notification strategy | Legal sends discontinuation notices reactively post-decision | Notification sequencing planned concurrent with portfolio analysis to avoid supply disruption findings |
| Post-merger applicability | Requires re-scoping for acquired portfolios; prior work rarely transferable | Framework adapts to acquired portfolio structures within two weeks using standardized intake templates |
| Board-ready output | Consultant deck with revenue waterfall and high-level rationale | Decision memo with per-SKU regulatory risk rating, estimated stranded cost recovery, and implementation sequencing |
The companies that recover the most value from rationalization aren't the ones who cut the most SKUs — they're the ones who sequence the cuts correctly.
Standard FDA Pre-Sub Process
vs. Guided Regulatory Sequencing
Pre-submission meetings are the most underutilized tool in the FDA submission toolkit. Most teams use them to get answers. The best teams use them to shape the question.
| Dimension | Standard Pre-Sub Process | Guided Regulatory Sequencing |
|---|---|---|
| Meeting type selection | Type B meeting requested by default for most NDA/BLA issues | Meeting type matched to specific question set; Type C used strategically to avoid 30-day clock where feasible |
| Question package construction | Questions drafted by regulatory team and reviewed by legal; submitted as written | Questions stress-tested against prior FDA responses in the same therapeutic area; ambiguous questions reformulated before submission |
| Background package scope | Full program history included; document volume often exceeds 200 pages | Package scoped to the specific questions; reviewers read what matters, not everything that exists |
| FDA response handling | Response reviewed by team; follow-up actions assigned in next weekly meeting | Response analyzed within 48 hours using structured decision matrix; follow-up actions logged with owner and deadline before end of day |
| Timeline management | Calendar-driven; meetings tracked against FDA PDUFA clock | Decision-driven; each FDA interaction mapped to a specific program decision that must be made before the next submission milestone |
| Post-meeting documentation | Meeting minutes filed; action items tracked in project management system | Meeting minutes structured as a regulatory position paper; suitable for IND/NDA incorporation without rewriting |
An eighteen-month review cycle is rarely an FDA problem. It's usually a question-framing problem that hardened into a timeline.
The Portfolio
Rationalization Playbook
The same analytical framework we use in client engagements — adapted for internal regulatory and commercial teams. Forty-two pages covering SKU-level scoring methodology, FDA notification sequencing, and the eight questions every board memo needs to answer before a discontinuation decision reaches the table.
Three ways Prescribe
engages with clients
Portfolio Rationalization
6–8 week engagement. Prioritized discontinuation list with regulatory risk ratings and stranded cost recovery estimates.
FDA Submission Sequencing
Pre-submission strategy through advisory committee preparation. Structured to move the program, not just the meeting.
Post-Merger Integration
Regulatory portfolio normalization for acquired assets. We know what the due diligence missed.
Thirty minutes.
One question answered.
Bring us your most pressing portfolio or regulatory challenge. We'll tell you what we see, what it costs to ignore it, and whether we're the right firm to fix it. No obligation. No slide deck.
Response within one business day. Engagements typically begin within three weeks.