Regulatory Strategy
APCER works together with clients on the strategic planning of regulatory submissions with US and European Authorities.
Regulatory Intelligence
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.
Submissions
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.
Together to gain approval
In addition to performing regulatory submissions of individual case safety reports (ICSRs) and aggregate safety reports, APCER supports life sciences companies in gaining approval for marketing new products worldwide. APCER is experienced in preparing and compiling filings to regulatory agencies in the US, Canada, India, Africa, South America, and Asia, as well as in the European Union under the Mutual Recognition Procedure (MPR) and through national and centralized filings. Its Regulatory Affairs team helps clients with product selection, filing strategy, and approach, performing all the necessary regulatory activities throughout the lifespan of a product.
Together to stay in compliance
APCER builds customized regulatory solutions with an understanding of the size of the organization, the number of products and marketing authorizations, case load, therapeutic class, and other relevant parameters to ensure a client is always in compliance and the process remains cost effective. We work together as the regulatory compliance expertise on your team of research and development, manufacturing, and quality organizations, or serve as the liaison with regulatory agencies on your behalf.
