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 integrity, and Six-Sigma/Lean principles that ensure our ERP Regulatory Compliance Solutions are unmatched in quality and cost.
Improved FDA & EMA Interactions
Kymanox professionals include former government regulatory personnel, life science Subject Matter Experts, and Global ERP Implementation Specialists who eliminate the ambiguity surrounding regulations, systems, process requirements, and published guidance. We make requirements of regulators, internal ERP processes, and their required outputs clear and well-documented. As a result, our partner’s implementations and interactions with the FDA and EMA are more confident, efficient and productive for reviews.
Kymanox CSV Toolkit®
Our proprietary project accelerators and tools, offer unparalleled leverage to rapidly complete your ERP Regulatory Compliance initiative with pre-defined, industry-proven, process, procedural, budget, training, language and scheduling templates. Our Computer System Validation (CSV) Toolkit® is package independent and may be employed throughout the full lifecycle of your ERP engagement or at select phases on the implementation roadmap that require tactical support in troubleshooting.
Practical Hands-on Experience
Kymanox has a diverse body of work, practice, and professional experience – exclusively focused on life sciences. The bulk of our practice is centered on SAP®; client partners who run Sage and Great Plains/MS Dynamics are also expertly supported. We understand your business in a way that translates into collaborative, cost-effective solutions, unmatched in providing ERP Compliance and Regulatory services.