Improved FDA & EMA Interactions
Good Clinical Practice Compliance Solutions
We are a premier global provider of compliance, advisory, and implementation solutions – with a focus on Clinical Quality Management Systems. As pragmatic client advocates, we offer a patient-centric approach, leveraging our past performance in the complete product lifecycle, from pre-clinical through commercialization and post-marketing activities. We help ensure well-controlled studies support your filings.
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 Clinical Practice Toolkit™
• Third Party Audits and Vendor Management of contracted services
• Development and delivery of customized Good Clinical Practice Training
• Good Documentation Practices and Data Integrity implementation and monitoring
• Clinical Trial Material and Investigational Medicinal Product support
• Investigator Site Audits and Quality Agreements
• Regulatory Inspection Preparation (i.e., Mock Audits)
Our overall approach is synchronized with FDA and EMA statutes, ICH guidelines, and patient-centricity. We utilize practical life science experience, sincere advocacy for patient safety, and expert project planning to proactively manage scope, schedule, and budget. Our toolkit includes rapid knowledge transfer and on-boarding, knowledgeable on-demand resources, real risk management, data integrity, and advanced Good Clinical Practice statistics.
Kymanox professionals include former government regulatory personnel, biomedical scientists, statisticians, Clinical Subject Matter Experts, Software Validation Engineers, and global quality assurance and regulatory compliance professionals who eliminate the ambiguity surrounding regulations, systems, study requirements, and published guidance. We ensure requirements of regulators, internal processes, and their required outputs are clear and – most importantly – well-documented. Our clients experience interactions with the FDA and EMA that are more Predictable, Efficient, and Productive with fewer delays, nonconformities, and citations.