Case Studies

Due Diligence: Data-Driven Analysis Supporting Acquisition Decision for Global Technology Firm

Project Overview

A start-up biopharmaceutical company with a late-stage development asset engaged NGT BioPharma Consultants to prepare a comprehensive End-of-Phase 2 Product Development Report. The report was intended not only to assess the company’s Chemistry, Manufacturing, and Controls (CMC) strategy but also to define the roadmap for achieving commercial cost-of-goods (COGs) targets. The document would serve as a technical and strategic foundation for presentation to a potential commercial partner and investor.

The Challenge

The client needed to translate complex CMC development data into a clear, investment-ready strategy that aligned technical soundness with commercial viability.

Key gaps existed in the regulatory and technical development plans, including API and drug product process definition, validation readiness, and COGs optimization.

The company faced pressure to produce a professional, data-driven report capable of earning confidence from both internal stakeholders and potential partners.

Our Approach

Developed a comprehensive regulatory and technical development report integrating cost-reduction levers and a phased plan for finalizing the API and DP commercial processes.

Conducted an eCTD submission gap assessment, reviewing critical process parameters (CPPs), critical quality attributes (CQAs), and material attributes to ensure regulatory readiness.

Formulated a regulatory starting-material strategy to streamline supply-chain qualification and reduce compliance risks.

Introduced a digital validation lifecycle management solution tailored to the client’s scale, incorporating risk- and knowledge-management workflows aligned with current GMP expectations.

Provided a strategic roadmap for integrating these elements into the End-of-Phase 2 report, ensuring alignment with both FDA and partner expectations.

Outcome / Impact

The resulting development report became a cornerstone document for partnership discussions, combining scientific credibility with financial and regulatory insight.

The proposed COGs reduction plan and optimized CMC strategy were endorsed by the commercial partner, validating NGT’s recommendations.

The client successfully secured new financing and advanced confidently into Phase 3 clinical development with clear regulatory and operational alignment.