Emerson Consultants approaches regulatory affairs strategically, rather than as an isolated discipline. Integrating regulatory affairs into the overall strategic plan early will speed approval and help ensure stronger product claims and positive reimbursement.
In consultation with the client, we develop a claims matrix and take a broad look at the clinical activities required to support those claims both for regulatory and reimbursement purposes. We then prepare the submission to meet regulatory and reimbursement requirements.
We monitor changing regulatory requirements carefully and maintain close ties to key personnel in governmental agencies. When appropriate, we present directly to legislators on behalf of clients, and participate in medical and professional societies to track the latest technological breakthroughs and changes in clinical practice.