Regulatory Affairs
SentinelRX works together with clients on the strategic planning of regulatory submissions with US and European Authorities.
SentinelRX tracks regulatory changes around the globe and provides updates applicable to your company’s product applications.
SentinelRX works together with clients on the strategic planning of regulatory submissions with US and European Authorities.
SentinelRX provide submission services to regulators and Competent Authorities worldwide, electronically wherever possible, through hosted production and document management systems.
Based on post-marketing safety experience, SentinelRX prepares and submits updates to the Summary of Product Characteristics (SmPC), patient information leaflets, and product labelling.
SentinelRX prepares and manages a complete response to questions received from Health Authorities, particularly those related to product safety that may arise from PSURs and other reports submitted.