Case Studies

Strategic 505(b)(2) Roadmap Enables Data-Driven Go/No-Go Decision for Rare-Disease Candidate

A small pharmaceutical company acquired a compound with extensive Phase 2b cardiovascular data and sought to repurpose the molecule for...

From FDA CRL to BLA Readiness: NGT Leads Regulatory Turnaround for Rare Disease Candidate

A small biotech company developing bentracimab, a novel biologic, sought regulatory support after receiving a Complete Response Letter (CRL) from...

Turning Failure into Opportunity: PK Data Mining and Microdosing Strategy Revives Early Clinical Program

A mid-size biotechnology company faced a significant setback when its lead compound, a novel therapeutic in early clinical development, failed...

From Data to Decision: Strategic CMC Development and Cost Optimization Empower Late-Stage Partnership Success

A start-up biopharmaceutical company with a late-stage development asset engaged NGT BioPharma Consultants to prepare a comprehensive End-of-Phase 2 Product...

Pharma-Focused Due Diligence Drives Data-Backed Acquisition Decision for Global Technology Firm

An international technology company exploring expansion into pharmaceutical manufacturing engaged NGT BioPharma Consultants to provide industry-specific due diligence in support...