Experienced Partners for Development and Implementation
For pharmaceutical, biotech, and medical device manufacturers, Quality Management Systems (QMS) are the foundation for enabling the organization to operate in a compliant manner. The QMS establishes the path to compliance for the company and enables sustainable systems that meet the demands of regulators, customers, and ever-changing business environments.
We are a trusted partner in designing, building, and managing QMS programs. Our industry-leading experts understand the complex regulatory elements and the compliance systems that are required for your organization to succeed. We can help guide your team through the regulatory processes specific to your quality programs.
Our professionals ensure QMS achieves three objectives:
- Continuous improvement
- Regulatory requirements
- Establish “right-sized” processes for the phase and scope of the organization
Global Compliance Experts
Whether you are proactively or reactively looking to develop and implement a QMS, our team can help.
Embracing the principles of the International Conference on Harmonization Q10 (ICH Q10) model, our global experts certify your QMS can verify that required product quality is routinely met. Our team makes sure that suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.