Work described by the regulatory events that defined it
No invented percentages or timelines. Each entry leads with the specific regulatory or development event, then sets out the challenge, the approach, and the outcome.
A rare-disease program sponsor
A 505(b)(2) roadmap for a rare-disease candidate
The sponsor of a rare-disease candidate needed a defensible regulatory route and a clear basis for deciding whether to continue the program.
Outcome
The roadmap enabled data-driven go/no-go decision-making, giving the sponsor a documented basis for its program decision.
A small biotech
A BLA resubmission after a Complete Response Letter
A small biotech developing bentracimab, a novel biologic, received a Complete Response Letter that raised CMC findings against its BLA.
Outcome
The program secured a positive Type A meeting result, moving the biologic back onto a forward path.
A mid-size biotech
Revitalizing an early clinical program after a lead-compound setback
A mid-size biotech faced a setback with its lead compound and needed a way to keep its early clinical program moving.
Outcome
The PK data mining and microdosing strategy revitalized the early clinical program.
A start-up
Diligence supporting a late-stage asset acquisition
A start-up's late-stage asset was being evaluated for acquisition by a global technology firm, which needed a clear read on the asset.
Outcome
The analysis supported the start-up's late-stage asset acquisition by a global technology firm.
An international technology company
Validating a manufacturing strategy for a company entering pharma
An international technology company expanding into pharma manufacturing needed to confirm its CMC strategy before committing further.
Outcome
The company validated its strategy, reduced costs, and secured late-stage investment and a commercial partnership.
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