White Papers

The Key to Finding a Trusted Regulatory Submission Management Partner

Regulatory submission management is a vibrant collection of resources, practices, and tools that are combined to support the regulatory submission lifecycle for a product, device, or therapy. It demands regulatory knowledge, technical expertise, proactive planning, and operational excellence. A good submission management function is efficient, compliant, responsive, and flexible. The broad umbrella of submission management is complex and constantly evolving.

A good Regulatory Submission Management Partner (RSMP) offers enough expertise to protect their customer from the traditional chaos, trauma, and drama of a regulatory submission. Those aspects are no longer the necessary evils that they once were.

This paper outlines regulatory submission management capabilities, details the barriers to building capabilities, and discusses the benefits of employing an outsourcing strategy to achieve them.

Technical Rejection Criteria: Are You Ready?

The U.S. FDA has established new requirements for data standards that will apply to most trial data submitted to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The agency has noted two important dates that determine how a Sponsor should approach and interpret the updated technical rejection criteria.

This paper will explain the updated technical rejection criteria (TRC) and the impact the updated criteria will have on your submission. It will also make recommendations regarding processes and share points to consider as Sponsors implement and validate against the new criteria.