The complexity of drug development and the associated registration process requires a combination of regulatory intelligence and scientific know-how. Our regulatory experts offer both. We will support you from the first stages of development through to submission of the marketing authorization application and beyond.
Our experienced RA team ensures a comprehensive regulatory strategy in order to achieve all major mile stones ranging from your Target Product Profile development and early engagement with the regulators on your (pre)clinical plan through to final marketing authorization application and maintenance activities once your product is on the market. Our RA team can develop your global regulatory strategy and support you with authoring, reviewing and submission of all regulatory documents pre and post approval.
Our regulatory experts can work together with your own (pre)clinical and CMC experts or you can benefit from 3D-PharmXchange in-house multidisciplinary team approach on offer. We can advise you on your early development plan or provide you with a complete package in the form of submission ready briefing book for scientific advice, Orphan drug designation application, EMA PRIME submission, Pre-IND meeting, Pediatric Investigation Plan (PIP) or waiver request, or a complete clinical trial application (CTA) package including the CMC section (IMPD/IND). We can also support you to request Small and Medium Enterprise (SME) designation making your company eligible to reduced agency fees.