Regulatory Affairs and strategic Planning for the Medical DEvice Industry
Oversight of Regulatory Affairs Departments
Regulatory Submissions and Communications
Labeling and Promotional Review
Regulatory Testing Plans
Working with us allows your company to leverage our knowledge without having to:
We offer three levels of engagement:
identify the deficiency and outline necessary correction
identify the issue(s); outline the correction; and provide new templates, protocols, and staff training
identify the issue(s); outline correction(s); provide templates, protocols, and staff training; and be there for continuous support to ensure that the corrections are permanent and staffing is efficient. This option often results in a net savings because of the staffing efficiencies that RCB allows in-house.
RCB ensures the regulatory process is efficient & strategic
We work directly with regulators on your behalf
allowing you to receive information from regulators without direct engagement
Our long term clients include Fortune 500 Companies, mid-sized device manufacturers, and start-ups—they have a few things in common.