The development of a new medicinal product is an extraordinarily complex process. There are inherent difficulties in successfully running a drug development programme. From drug discovery to market approval, the larger or the more innovative the project, the more numerous potential challenges can be.
Together with your team we will identify prerequisites, define activities, timelines and milestones that are necessary to reach your regulatory goals. Regulatory Project Management expertise is essential for successful, on-time and on-target delivery of a drug development project.
We support you with:
- Regulatory strategy
- Management of multidisciplinary project teams
- Preparation and implementation of an integrated project development plan
- Interactions with Regulatory Agencies such as Scientific Advice (SA), Paediatric Investigational Plan (PIP), Orphan Drug Designation (ODD) etc.
- Coordination of INDs and the information requests (IR) in the USA
- Coordination of core documents for Clinical trial Applications (CTA) and requests for supplementary information (RSI) in Europe
- Coordination of marketing applications such as Marketing Authorisation Applications (MAA), New Drug Applications (NDA), Biological License Application (BLA) etc.
- Support for Small & Medium-Sized Enterprise (SME) requests
To ensure that the various elements of your project are well coordinated, we can assist you in shaping your project by integrating our experts into the team. In addition, we can guide you on outsourcing aspects of your project, managing partners and achieving the optimal performance from third parties.
