Our expert, proven team will guide you through the regulatory procedures to ensure timelines are predictable for even the most complex clinical trial applications.
Ergomed’s regulatory affairs team routinely navigates the global regulatory nuances for a broad range of investigational medicinal products (IMP), advanced therapy medicinal products (ATMP), genetically modified organisms (GMO), medical devices, diagnostics and combination products.
We provide both strategic and local pharmaceutical regulatory affairs expertise, helping to facilitate approvals from national regulatory agencies and ethics committees (IRB/IEC) for phase I-IV trials, non-interventional /observational studies and device investigations.
Our clinical trial applications teams are adept in the development and review of scientific/technical core study documents, delivery of internal gap analysis and proactive mitigation of risk.
Through our proprietary regulatory intelligence database, coupled with performance metrics, we excel at developing regulatory submission strategies that yield optimal execution plans and rapid study start-up.
Our clinical trial applications services include:
- Pharmaceutical regulatory affairs consulting
- Pre-IND/CTA meeting, development of briefing package for scientific advice
- Input to protocol development, feasibility and country selection
- Definition of regulatory submission strategy, development of risk mitigation plans
- Authoring/review of technical and scientific submission documents, such as INDs and IMPDs.
