Strategic and tactical regulatory support are critical to a robust and reproducible clinical trial program in preparation for application for licensure to any global regulatory body. Without a correctly structured program, regulatory applications are more subject to delays or rejection. DHC provides support from subject matter experts with extensive experience in both clinical trials and global regulatory filings.
We help you to define and strategize your clinical trial structure from First-in-Human (Phase 1) through to Registrational (Phase 3). We can provide recommendations on the programs and designations applicable to your program, such as US FDA designations [fast track, breakthrough therapy, regenerative medicine advanced therapy (RMAT), orphan drug, rare pediatric disease, advanced manufacturing technology, platform technology] and FDA expedited programs [fast track, breakthrough therapy, regenerative medicine advanced therapy (RMAT), accelerated approval, and priority review] or EU special procedures and programs [classification as Advanced Therapy Medicinal Product, certification of quality and non-clinical data, PRIME (Priority Medicines), and Orphan Medicinal Product]. We can also assess the program's readiness for optimal timing of your submission.
Our experienced technical writers can provide a full range of support for your filing needs, from individual sections (we support the full range of contents: Administrative, CMC, Nonclinical, Clinical...aka, Modules 1-5 of the eCTD) to authorship of full documents. We also offer review, gap analysis, and editing of your existing draft documents. Our team’s diverse experience spans a wide range of global jurisdictions and stages of development, from preclinical (INTERACT, pre-IND, Scientific Advice, IND, IMPD, CTA) through clinical (meeting packages, designation requests, IND protocol documents) and marketing approval (BLA, MAA). Click here for a list of supported regulatory documentation.
When convening a Medical Advisory Board, it's necessary to select an appropriate group of KOL's (Key Opinion Leaders) who understand both the indication in question and the unique challenges and considerations of developing a CGT product for that indication. Working with the right group of medical advisors is critically important to allow for proactive identification of strengths and weaknesses in a clinical development program so as to catch any potential limitations early in the development process. DHC experts work with the vast majority of KOLs in the CGT space and have supported convening and running of medical advisory boards for a range of purposes, from indication selection and clinical protocol development for therapeutics developers to opining on strength of clinical data in due diligence projects.
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