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Pharma Development Solutions specializes in the early phases of product development, advancing biomedical research through Phase 2 clinical trials. We work directly with emerging companies and academic researchers to plan a preclinical program that integrates basic research with other technical domains to support an IND/IDE for a specific clinical indication. We also assist researchers in preparing their summaries and reports for incorporation into IND/IDE technical reports, investigators brochures and other clinical/regulatory documents. We work with clinical and regulatory experts to prepare and submit the initial IND/IDE. After the IND/IDE has been cleared by FDA, we continue working with companies in clinical and regulatory affairs as well as in project management. Our services include:

 n Development of a pathway to the IND/IDE
 n Regulatory and clinical guidance
 n Project management
 n Document and communications support

We work with pharmaceutical, biotechnology and medical device companies, contract research organizations, financial groups, and academic/non-profit research institutions.

 

NOTE: IND = Investigational New Drug Application;  IDE = Investigational Device Exemption