Clinical Trial Applications
Areas of support include:
- CTA project management
- Document authoring and coordination
- Competent authority submissions
- Ethics submissions
- GMO applications
This phased approach includes:
- Preparation and submission of clinical trial applications and following amendments to the competent authorities and to the ethics committees; check the progression of the applications until approval
- Data entry on behalf of the sponsor into the EU databases for clinical trials
On demand regulatory team an Assion case study
A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.