The Situation
- An early-stage Canadian pharmaceutical company was developing a drug product for COVID-19 treatment.
- The company engaged EVERSANA’s Regulatory Consulting to assist in the gap assessment of Chemistry, Manufacturing, and Controls (CMC) information already generated for future authoring of NDA application.
- Challenges with Phase II patient enrollment led to additional project scope and the need for regulatory strategy support.
The Solution
- EVERSANA’s Regulatory Consulting worked closely with the client team to obtain all CMC documentation already generated and perform a gap assessment for NDA submission purposes.
- EVERSANA’s Regulatory Consulting worked with the client to develop an alternative regulatory strategy when client was faced with Phase II enrollment difficulties. EVERSANA REGULATORY CONSULTING stepped in and proposed a path to perform one Phase III study for submission purposes and helped draft a meeting request packet for FDA to discuss viability of alternate path. The meeting with FDA allowed the company to gain certainty on its label, regulatory pathway, intended use, risks, and clinical development plans.
The Results
- CMC gaps identified, summarized, and communicated to the client. A remediation plan was also generated and provided to the client.
- The client’s clear regulatory and clinical roadmap for its product were critical in the company’s subsequent raising of additional funding for the Phase III clinical study.