Regulatory and medical expertise to treat the most vulnerable patients
Regulatory activities in clinical trials are often parceled out to experts because FDA/EMA and country level knowledge is so important to the success of a trial. Strategic insight from the development stages through commercialization and oversight of functional services play an important role. Getting products to patients, especially advanced therapies, orphan drugs and medical devices, requires specialized knowledge.
Orphan drug program designs, provided by our regulatory experts
across the US and EU, have provided pathways for many orphan drug designations. Our innovative trial designs include critical activity for approval while our medical advisors, submission writers and data analysts also serve as agency liaisons.
Two-thirds of rare diseases can potentially be cured by gene therapy. Due to the parallel of rare diseases to advanced therapies
, we have also worked on over 25 projects in cell and gene therapy. We specialize in authorizations for GMO voluntary release, documentation, early phase design and Good Distribution Practice, making us the ideal choice for your innovative ATMP.
We similarly apply our regional and local knowledge to all classes of medical devices. Since country regulators are dissimilar from each other in devices, we help ensure products meet FDA, EMA and all other required standards.