NGT BioPharma Consultants is mindful that contemporary drug development emphasizes quality data, informed decision-making, and speed. Early- and late-phase development are intended to be seamlessly integrated and, at times, combined. Our expert consultants and interconnected provider network are highly experienced in the many integrated facets of late-phase development, beginning at or before Phase 2 and continuing through registration, commercial launch, and life cycle management.
The NGT team coordinates and manages client-customized API/DP process development/supply, clinical development, regulatory strategy/submissions, and quality/compliance programs to expeditiously attain marketing approval and achieve commercial success. We work collaboratively with our customers to mitigate risk while maximizing their drug products’ safety, efficacy, and commercial value. NGT provides the following Strategic and Operational services:
LATE-STAGE CMC & CLINICAL DEVELOPMENT
Michael K. O’Brien, PhD
President & CEO860-207-8135
CASE STUDY – Late-Stage Development Report
A start-up company with an asset ready to enter Phase 3 enlisted the support of NGT’s consultants to prepare an end of Phase 2 product development report, which was to include an assessment of the company’s CMC strategy and an articulation of the steps necessary to achieve the commercial cost of goods target. The start-up company executives indicated that the report was also to be presented to a potential commercial partner.
NGT’s consultants created a regulatory and technology development report that included levers to reduce the cost of goods and a framework for finalizing the API and DP commercial processes. NGT’s consultants also performed an eCTD submission gap assessment (e.g., evaluation of critical process parameters, critical quality attributes, and material attributes) and provided a regulatory starting material strategy. In addition, a digital validation lifecycle management solution was introduced to fulfill validation requirements, including customized risk and knowledge management processes.
The commercial partner endorsed the cost of goods reduction proposal and other CMC recommendations enabling the start-up company to secure the finances necessary to proceed into Phase 3.