Regulatory Science
Teamit accompanies researchers in early dialogue with regulatory bodies to plan a smooth progression from research results to real-world applications. Our expertise is focused in navigating regulatory procedures and the preparation of documentation in basic research, pre-clinical research and post-marketing authorisation.
Regulatory strategy
Definition of the regulatory roadmap for medicines, therapies, devices and methodologies development.
Regulatory landscape
Comprehensive analyses of the current regulatory environment regarding the specific area of interest.
Regulatory comparator cases review
Analysis and evaluation of relevant regulatory comparator cases.
Early regulatory engagement
EMA Scientific Advice and protocol assistance; Qualification of novel methodologies for medicine development; Innovation Task Force briefing meeting.
Hands-on Experience
Teamit brings its regulatory science expertise to a number of projects and initiatives like FIBROTARGET, WidenZymes or PHOTOTHERAPORT. In the past, it has also led Innovation Task Force briefing meetings with the EMA on behalf of RESCUE and EU-PEARL projects and the Institute for Bioengineering of Catalonia (IBEC) and supported the qualification of Minimal Disease Activity Score (MDA) as primary outcome instrument for clinical studies in psoriatic arthritis (PsA).
