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Strategic planning of regulatory submissions with US and European Authorities.
Tracks regulatory changes around the globe and provides updates applicable to Client’s product applications.
Complete response to questions received from Health Authorities, particularly those related to product safety that may arise from PSURs and other reports submitted.
Prepares and submits updates to the Summary of Product Characteristics (SmPC), patient information leaflets, and product labelling.
Provide submission services to regulators and Competent Authorities worldwide, electronically wherever possible, through hosted production and document management systems.
GLOBVIGILANCE tracks regulatory changes around the globe and provides updates applicable to your company’s product applications.
