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.


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.


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


We provide several GCP solutions that leverage our extensive experience with Quality Management Systems developed for the most demanding biologic, drug, and device programs. 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.

Click here to view how we Solve the 5 Most Common Issues in a GCP Study.

Click here to view our GCP services summary (1 page PDF).

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