Regulatory Operations

APCER helps clients develop a filing strategy and perform regulatory activities worldwide throughout the lifespan of a product.

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.

• Regulatory Strategy
• Regulatory Intelligence
• Approval Lifecycle Management
• Submissions
• Product Labeling Maintenance
• Responses to Health Authorities

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.