SERVICES

We provide input to preclinical POC and toxicology study designs, clinical study designs, corporate/ portfolio/ program strategy, regulatory strategy (including special regulatory pathways [i.e., orphan and fast track designations]), provide phase-appropriate CMC strategy, support due diligence and business development activities, and think critically across disciplines (CMC, translational research, preclinical POC and toxicology, clinical) to assist your team in troubleshooting/ navigating obstacles to get your program back on track. 

Preparing an Investigational New Drug (IND) or an Investigational Medicinal Product Dossier (IMPD) that can satisfy the regulatory agency is a substantial undertaking. Coordinating the effort requires an understanding of how each section of the dossier supports the overall submission, the necessary content and level of detail required, and how to address limited data on the investigational drug at the time of submission. At PDC, we are experienced in authoring, reviewing, coordinating, and submitting INDs/IMPDs. We can guide your team smoothly through the planning, writing, review, and submission process. If you have not yet had a Pre-IND or Scientific Advice meeting, we can help you request the meeting, define the questions to be asked, and prepare the briefing document in advance of the meeting. Following your IND/IMPD, we can support ongoing interactions with the agency, including specialty applications (i.e., orphan and fast track designations).