Six Mistakes Made in a CGxP Quality Audit and How Kymanox Avoids Them

Kymanox can help you with all of your auditing needs, ensuring cost-effective, solution-based approaches so that your audits are not only compliant, but successful and business-smart. Our responsive, expert-led teams are rich in knowledge and experience spanning all aspects of the life sciences, including biomedical research, academia, executive-level pharmaceutical quality management, and other industry leaders. Kymanox’s experts will have you …

SAP / ERP – FDA Compliance

Quality by Design (QbD) & Patient Centricity Our overall approach to providing solutions is based upon the principles of Quality by Design (QbD) and patient centricity.  In addition to the standard ISO and ICH methodologies, we leverage practical life sciences experience, sincere advocacy for patient impact, expert planning, and sound engineering.  We utilize rapid knowledge transfer, real risk management, data …

Combination Product Compliance

In the United States, a combination product is any product composed of a combination of a drug and a device, a drug and a biological product, a device and a biological product, or a drug, a device, and a biological product. Combination products are divided into three categories: single-entity, co-packaged, and cross-labeled combination products. Single-entity combination products are comprised of …

Good Clinical Practice Compliance Solutions

Practical Hands-On Experience Kymanox has a diverse body of work, practice, and professional experience – exclusively focused on the life sciences. We understand your business in a way that translates into collaborative, cost-effective solutions. We provide: • Clinical Quality Management System Development and Optimization • Clinical Compliance Gap Assessments • SOP Development, Training, and Implementation based on our KymanoxWORKS™ Good …

Data Logging & Mapping

We have all bought something that didn’t quite work the way we wanted. We get home, we set it up, and in the end, we get a dose of disappointment. Hopefully it can be returned and all we have wasted is time. However, in the world of compliance, a piece of equipment that does not work the way it needs …