Continuity of support throughout the product life-cycle
Thanks to the unique business model that constitutes the FGK group of companies we can offer single point of contact to our clients providing continuous support from the initiation and conduct of the clinical phase of the product development through preparation of analysis and documentation necessary for marketing authorization and to the post-authorization phase.
We:
support you in drafting and submitting documents required for initiation and conduct of clinical phase of product development
- setup and coordinate the safety information flow from various sources (clinical trials, investigator initiated trials, named patient use, etc.)
- keep the safety information stored in a single dedicated safety database
- provide tools to periodically analyze the collected safety data to assess the risk-benefit profile of your product
- centralize generation of regulatory reports and their submission to competent authorities globally
- support you in generating and analyzing data outputs and drafting documents required for compilation of product dossiers required to place your product on the market
- support you in transitioning and during post-authorization phase of the product life-cycle.