Regulatory Affairs and strategic Planning for the Medical DEvice Industry
Regulatory Affairs for Medical Device Manufacturers
Regulatory Submissions and Communications
Training & Oversight of Regulatory Affairs Departments
Labeling and Promotional Review
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.