Flexible and Bespoke Regulatory Services
The regulatory consultants at Orphix are dedicated to providing professional, flexible regulatory services tailored to meet the specific needs and preferences of clients. We recognise the distinctive nature of each project and work to maximise successful outcomes. We also have access to a broad international network of experts who can provide specialist support to client projects when required.
The philosophy at Orphix is to provide honest, forthright advice to facilitate quality decision making and to offer creative solutions to developmental and regulatory challenges. Our multidisciplinary team of scientists can support clients because they have research and regulatory affairs expertise across the spectrum of disciplines required for successful drug development.
Orphix provides high quality management solutions for drug development projects. We offer:
- Detailed evaluation of the strengths and weaknesses of the client’s data in drug development plans
- Recommendation of an appropriate strategy, which meets both client and regulatory agency expectations for licensure
- Assistance in the implementation and execution of the planned strategy
- Rapid evaluation of the client’s scientific and regulatory situation, in the event of EU regulatory agency rejection
- Provision of a report with recommendations including options for re-examination