Regulatory Affairs and Pre-Registration Activities

Critical efficacy interpretation and pre-registration safety surveillance drive how drugs are labelled and positioned. TranScrip Partners have a track record of being clinical and regulatory leads on several successful regulatory submissions both in Europe and the US. Their expertise encompasses initial scientific advice meetings, writing of the Common Technical Document modules, answering regulatory questions and preparing for CHMP or FDA hearings. TranScrip's interest in driving clinical and regulatory guidelines brings them into contact with the regulatory movers and shakers. Partners understand the importance of submission timelines and will work long and flexible hours to ensure all potential issues that might arise are properly addressed. They are also aware of how closely they must be aligned with the marketing and commercial positioning of the product to provide continuity into the clinical and regulatory aspects of the launch.