The Investigational Drug Application (IND) and Investigational Medicinal Product Dossier (IMPD) mark a major milestone for drug candidates - namely, the ability to begin human clinical trials in the US or Europe, respectively. Creating a complete application that can satisfy the regulatory agencies is a substantial undertaking, requiring the input of Subject-Matter Experts from many … Continue reading Need help with your IND or IMPD?
Category: Regulatory
E4 Consulting specializes in providing Pharmaceutical Development, Regulatory Affairs, Quality Assurance and Project and Portfolio Management expertise to biotechnology and pharmaceutical clients. We provide both strategic and operational assistance to companies that are bringing new drug, biologic and device candidates into clinical trials and to market. Moving a research compound into human clinical trials is a daunting … Continue reading How we can help you reach the IND and beyond