Essential^SM Quality Assurance offers a range of services that are governed by Good Clinical Practices (GCP) and ICH guidelines and supported through the in-depth training and experience of our auditors. Our QA services include individual site audits, document and system audits, and investigator-directed audits. Successful management of clinical trials depend on a thorough understanding and implementation of the nuances of GCP and ICH guidelines. At Essential, QA auditors are constantly evaluating these standards with the overall goal of quality and compliance.

At Essential, our regulatory experts will become working partners in the strategy and design of your clinical development program. Utilizing a full understanding of current regulations and the regulatory environment, we can help to reduce development timelines and ensure expeditious review. Our accomplished regulatory affairs experts can be utilized to prepare a full drug development plan, or to plan for an individual clinical trial. We also provide regulatory consultation in the areas of product development planning, preparation of clinical trial applications, and support through product approval by regulatory agencies.