Regulatory Consultants Group (RCG) provides services to medical device, in-vitro diagnostic, biotech, clinical research and pharmaceutical industries. We help you navigate the complex world of regulations, FDA inspections and more.
With the growing complexities in the international marketplace, compliance with the vast regulations is becoming increasingly important. Whether you are a startup or a large multinational company you can benefit from the experience and expertise RCG has to offer to meet your objectives in a highly cost effective way.
Supplier audits are a part of your regulatory requirements and is necessary for critical suppliers. Conducting thorough supplier audits is a good business practice and your responsibility to ensure proper manufacturing of components and products provided by outside vendors. Their compliance with the quality system regulations (QSR) and GMP regulations is critical and can cause serious problems to your company’s products if not properly monitored and controlled. We conduct supplier audits on your behalf to assess whether your critical suppliers are adequately addressing your requirements in accordance with applicable regulations
A Gap Analysis will help determine your current level of compliance with the appropriate quality regulations. The gap analysis is typically conducted for a system or particular area of concern and will help identify areas of deficiency or gaps in your system.
You should ask yourself if you have all the necessary written procedures and are your employees following them? If the answer is no, then you have "gaps" in your quality system. We are ex-FDA Investigators and industry professionals so we understand what items FDA investigators look for and if you are following the regulations. This is a critical process and can help you accomplish a successful inspection when the time comes.
A mock inspection will help evaluate the readiness of your company and quality systems. Our mock inspections are conducted by experienced and highly skilled former FDA Investigators and industry professionals who will treat the audit just like a real FDA inspection.
Your employees will gain a level of understanding for what is required, how to act during an audit and the mock inspection will educate the entire company on the workings of an FDA inspection. That type of authenticity will afford great advantage to your company when an actual audit is conducted. Let us help you in this process.