Did you know that…?
Our brand new web features a section called “SERVICES”. You can navigate through our services by choosing different approaches: by department, by stage of development, by product or by region.
Today we will tell you more about our Medical and Scientific writing unit, focused on providing you with support to build the foundations of strong non-clinical and clinical developments.
Our team has academic research experience and a broad scientific background in non-clinical, clinical and CMC writing for different types of products, including innovative, biological, biotechnological and advanced therapies medicinal products. Asphalion’s expertise allows us to offer the best regulatory strategy for each project.
We can support you with all sort of regulatory related documentation required during the clinical development and registration. In addition to this, strategic inputs can be provided from the very beginning for segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical development plans with minimal time-to-market, among others.
Among the many solutions of ad hoc Regulatory advice and strategic consultancy during product development we would highlight:
- Regulatory roadmaps
- Scientific Advice meetings
- Orphan Drug Designation (ODD)
- Paediatric Investigational Plan (PIP)
- Regulatory tools
- Support in Clinical Trial application in EU (preparation and submission)
- Common Technical Dossier (CTD)
Have a look here for additional, more detailed information:
For further requests, you can send us an email at: firstname.lastname@example.org