I3CGLOBAL UK supports strategic regulatory affairs activities with high added value to more procedural activities aimed at obtaining authorizations quickly and efficiently, guaranteeing both the quality and safety of medicines throughout their life cycle.
Our experience and versatility in regulatory affairs allow us to offer our customers a service tailored to the situation of each client, making it an easy way for commercialization of the product, saving time and money.
We offer our regulatory affairs services such as fda dmf 510k, European Authorized Representative Services, Medical Device CE Marking, Clinical Evaluation & Reports, UKCA Mark and more at the European level is centralized, decentralized, and mutual recognition procedures, coordinating regulatory activities with all the different member states and Drug Master File agencies supported by our knowledge of the specific requirements and procedures of the different countries of the European Union.
Also, we support foreign companies at the national level, as their local contact to help with all procedures and activities of regulatory affairs.
CLINICAL TRIALS
I3CGLOBAL UK Regulatory Affairs team has the experience and flexibility to provide a reliable and adapted service to our clients to act as a local contact in the UK, managing all regulatory activities to obtain authorization for clinical trials.
During the regulatory affairs phase, it is crucial to have experience and knowledge of bottlenecks to avoid delays in authorization that may have an impact on the development of the clinical trial.
For this reason, we coordinate operations for our clients between the promoter and hospital centers, researchers, ethics committees. Offering an efficient regulatory affairs service by delivery times.
