Regulatory Consulting

The team at EMINENT boasts extensive experience in managing quality clinical trial materials for Phase I to IV studies, alongside a deep understanding of current Good Manufacturing Practices (cGMP) as they relate to the development of clinical study products. Our personnel are also proficient in regulatory affairs, specifically familiar with the processes of filing Investigational New Drug Applications (IND), New Drug Applications (NDA), and Drug Master Files (DMF) with the U.S. Food and Drug Administration.

Our contract consulting services can be incredibly beneficial to small, research-driven pharmaceutical and biotechnology companies embarking on clinical drug development for the first time. Additionally, Contract Research Organizations (CROs) and Data Coordinating Centers (DCCs) involved in clinical studies will find value in our expertise, particularly in areas such as clinical product development, patient-specific packaging and labeling, distribution to clinical sites, and clinical site inventory monitoring. These services ensure that our clients can navigate the complexities of drug development with confidence and compliance.