REGULATORY EXPERT – CMC PHARMACEUTICAL CONSULTANT

Client Challenge

The client, a global pharmaceutical company, faced challenges in workload when they suddenly lost an internal resource. The client needed immediate support within the regulatory CMC function to assist with various deliverables and tasks. They required an experienced regulatory specialist with knowledge of global regulations and submission types. This person would provide CMC support of the technical CMC section for new products and/or marketed pharmaceutical products worldwide and would have extensive customer interactions with R&D functions, and other teams within Regulatory Affairs. Experience with preparing and editing submissions to include appropriate content, and submit it through the Gateway was also crucial.

Red Nucleus Solution

Red Nucleus was able to provide a regulatory professional with over 19 years of pharmaceutical experience to assist with the client’s projects. They had the knowledge and experience of developing and executing regulatory strategies and were familiar with international regulations and processes for drug development and/or product maintenance in various markets. They had direct knowledge of regulatory requirements for the demonstration of safety and effectiveness of products in clinical studies and a working knowledge of US and international regulatory requirements.

Value

The client was able to ensure business continuity without any risk in delivery by onboarding a Red Nucleus consultant to fill their resource gap. The Red Nucleus consultant was able to quickly become an extension of the client team, providing the needed knowledge, experience, and ability to work independently to meet or exceed expectations for project timelines.