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 our clients through regulatory planning and execution to help ensure compliance, accelerate product approvals, and reduce time to market.

Regulatory Affairs for Medical Device and In Vitro Diagnostics

• Strategic Regulatory Affairs planning

• Liaison to regulatory bodies

• Regulatory submissions (or, pre-review of Company-written technical documentation)

• Development and review of labeling

• Post-market-surveillance

• 13485 and MDSAP certification and audit preparation (gap analysis for FDA’s QMSR, or when moving from 13485 to MDSAP, etc.)

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