QUALITY AND REGULATORY COMPLIANCE
Regulatory Compliance Case Study
Ensuring the production of a quality product in full compliance of all regulatory agencies can be a daunting task for any organization. By involving Kymanox early in your process, Quality Assurance and Regulatory affairs will have the proper resources to be more proactive. Early engagement helps avoid the majority of potential issues which may impact product efficacy, patient safety, and your overall program.
A COMMITMENT TO QUALITY
Kymanox provides services using an approach based in Quality by Design (QbD). A universal quality system advocated by the FDA and other global governing bodies, QbD incorporates sound science, knowledge transfer, risk management, Process Analytical Technology (PAT), Six-Sigma, and LEAN among other technical and quality tools adopted by the Biotechnology, Medical Device, and Pharmaceutical industries. Kymanox’s full use of QbD returns higher product quality while saving your business time, money, and regulatory scrutiny.
With our access to world class expertise in every aspect of GMP, Kymanox can help your team develop internal processes which will work together to ensure product quality. Every system; documentation, controls, material management, QC, validation, etc. should be a part of the solution, not a part of the problem.
IMPROVED FDA INTERACTIONS
Let Kymanox guide your team through the ambiguity which surrounds FDA regulations and published guidelines. Our experience with FDA regulations allows Kymanox to clarify end-requirements for your organization, making FDA interactions efficient and productive. Kymanox has experience in both proactive and reactive solutions, organization of data for review, and developing logical and complete answers for complex and involved issues. Kymanox is able to assist with FDA interactions at all stages:
- IND, NDA, BLA, PMA and 510k Submissions
- Inspections and Audits including Pre-Approval Inspections (PAIs)
- Responses to Deficiency, Observation (i.e., 483), and Warning Letters
- DQ/IQ/OQ/PQ Validation
MINIMIZE SETBACKS
For examples of how our regulatory expertise has assisted other clients, check out our Regulatory Compliance case studies. For additional information on our Quality and Regulatory compliance services, please contact us. At Kymanox, we get projects DONE.
