Pharmaceuticals

We all know that the cGMPs are general, complex, and open to interpretation, but that doesn’t free pharmaceutical companies from developing a systematic approach to compliance.

PathWise has the experience in developing and managing quality systems that meet the challenges of regulatory compliance. Our solutions vary from client to client. But our commitment to transferring our knowledge of best practices and tools remains constant.

Typical solutions consist of one or more of the following:

  • On-site Training – our experts will simplify concepts, systems and processes. Whether you need help with Risk Management, CAPA, or another aspect of the cGMPs, our approach is ‘hands-on’ and ‘how-to’ driven.
  • Small Group Coaching – provides an intimate setting for us to work with your key personnel. Based on the issues you face, we’ll assign an expert to assist your team in solving your core issues.
  • Auditing – to review policies and procedures. We compare your systems to the FDA’s guidelines on the cGMP’s, identify possible problems, and make specific recommendations for fixing them.
  • Non-Compliance Investigations – we’ll facilitate your deviation investigations using our proven process. At the same time we’ll provide a common language, and a blueprint for your organization to follow during future investigations.

> Learn more about our methodology