APCER works together with clients on the strategic planning of regulatory submissions with US and European Authorities.
APCER tracks regulatory changes around the globe and provides updates applicable to your company’s product applications.
Approval Lifecycle Management
APCER supports filing of documents throughout the product lifecycle, from the IND, NDA, ANDA, CTD and eCTD, to Clinical Overviews, annual reports and periodic reports.
APCER provide submission services to regulators and Competent Authorities worldwide, electronically wherever possible, through hosted production and document management systems.
Product Labeling Maintenance
Based on post-marketing safety experience, APCER prepares and submits updates to the Summary of Product Characteristics (SmPC), patient information leaflets, and product labeling.
Responses to Health Authorities
APCER 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.