Real Regulatory can provide the expert regulatory strategy to efficiently gain approval for your product across Europe and around the world.
Clinical Development Consulting Services
- Provision of a flexible virtual development team from our panel of experts
- Advice on preparation of your Clinical Development Plan (CDP)
- Strategic advice on maximising efficiency of Clinical Trial Application (CTA) submissions and approvals using the Voluntary Harmonisation Procedure (VHP)
- Review of non-clinical data for entry into clinical development
- Advice on Target Product Profile (TPP)
- Advice on formulation development throughout clinical development
- Submission of request for Orphan Designation
- Preparation and submission of a Paediatric Investigation Plan (PIP)
- Preparation and submission for Scientific Advice across Europe and globally.
Project: PIP waiver submission to European Medicines Agency (EMA) for a biological medicinal product
Client: A mid-sized pharmaceutical company
Challenges: There were tight timelines for the submission due to its impact on filing of the Marketing Authorisation Application (MAA)
Our Solution: Real Regulatory included experienced experts in clinical and toxicology in the project early with regular meetings with the client. Also regular contact was maintained with the EMA to ensure that all submission requirements and deadlines were met.
Project: Voluntary Harmonisation Procedure (VHP) for clinical trial authorisation (CTA) submissions for an ophthalmic product Phase II trial across multiple European countries.
Client: Small Contract Research Organisation (CRO)
Challenges: Clinical trial set-up had tight timelines. In addition there are differing national interpretations of Clinical Trials Directive and guidance documents with different approaches to assessment and time-lines for approval. This leads to divergent decisions for the same clinical trial.
Our Solution: The strategy was to submit the CTA submissions using the VHP to meet the very tight timelines and avoid divergent decisions across Europe for the same clinical trial. The VHP for CTA submissions offers a co-ordinated assessment of multi-national clinical trials within the existing European legal framework. An electronic submission of core documentation was made to the VHP co-ordinator in a timely manner. Following a positive decision from the VHP, submissions to the national competent authorities were made using our local experts which allowed us to quickly and efficiently collect regulatory intelligence on local requirements. Regular strategy development meetings with the CRO and sponsor ensured that any potential hurdles were anticipated and quickly overcome. As a result, approval from the National Competent Authorities was received in a timely manner following the positive VHP decision.
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