Quality Assurance Consulting
One of the important steps in the medical devices, biologics and drug development process is the demonstration that it is safe to administer the product to humans for the first time (Phase I). The process is especially difficult because this demonstration of safety is most often limited to the use of preclinical in vitro and in vivo studies, including animal toxicology studies. In order to carry out this task, consideration must be given to the FDA regulatory process, the appropriate FDA and ICH guidance, general principles related to proper toxicology study design, specific safety considerations related to the biological product or drug class, additional safety concerns obtained from a careful scientific review of the pharmacodynamics and mechanism of action of the product, and an analysis of the risk-benefit issues associated with the product. The product development cannot proceed until preclinical toxicology study results that support safe administration of the product to humans are submitted to the FDA in a 510(k) or an IND. It is recommended this process involve continuous communication with the FDA, including a pre-IND meeting. It is imperative that this process employ rigorous quality standards.
The quality assurance services Walker Downey & Associates, Inc. provides are diverse and vary from one individual consultant to another based on the consultant’s expertise and experience. For the majority of our clients, we provide internal and external quality assurance audits for compliance with established regulatory standards, or against established/agreed upon product specifications. For all of our clients, we note that the “cost of quality” isn’t the price of creating a quality product or service. It’s the cost of NOT creating a quality product or service. In short, any cost that would not have been expended if quality were perfect contributes to the cost of quality.
Walker Downey & Associates, Inc. quality assurance consulting may include:
Our certified auditors/Associates have many years of experience in their fields including GLP and GMP audits. Please contact us at email@example.com to see how we may be of service to your team.Case Studies