RCB Regulatory Consulting, LLC

RCB Regulatory Consulting, LLC specializes in delivering expert regulatory affairs services tailored to the medical device and in vitro diagnostics industries. With deep industry knowledge and a strategic approach, we guide companies through complex regulatory landscapes to help ensure compliance, accelerate product approvals, and reduce time to market.

Regulatory Affairs for Medical Device and In Vitro Diagnostics

*Now offering eSTAR pre-review to help de-risk your submission. Clients have found this simple service to be helpful (especially when coming from different regions or submitting a novel device).

• Strategic Regulatory Affairs planning and execution

• Global regulatory submissions

• Liaison to regulatory bodies

• Development and review of labeling and promotional copy

•  International post-market-surveillance, vigilance reporting, and medical device reporting

• Recall strategy, coordination, and execution

• 13485 and MDSAP certification and audit preparation

WHY RCB

Some of the Benefits of Working with Us:

• Leverage our extensive regulatory knowledge and experience

• Gain clarity from effective and well-planned Q-submission interactions

• Ensure that your devices and diagnostics are well-positioned during the submission process

• Receive efficient planning and strategically-aligned responses to regulators

• Increase productivity without adding to your regulatory staffing
  

Examples of potential RCB Regulatory Consulting client collaboration:

1. Continuous support for several regulatory projects or audit preparation

2. Planning and execution of regulatory deliverables/submissions

3. Interactive review of client drafts

4. Identification of any needs or gaps, provide compliant templates, protocols, and staff training

RCB ensures the regulatory process is efficient & strategic

We work directly with regulators on your behalf, allowing you to receive information necessary for successful regulatory submissions

MORE ON OUR SERVICES

Our Clients

Our long-term clients, including Fortune 500 companies, mid-sized manufacturers, and start-ups, share several key advantages:

• Leverage RCB’s efficiency to eliminate the need for additional in-house staffing

• Gain time-, cost-, and resource-saving benefits through RCB’s expert Regulatory Strategy

• Rely on RCB-developed procedures to support ongoing regulatory and QMS compliance

• Maintain transparent communication, enabling RCB to anticipate and plan for future regulatory requirements