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QUALITY + COMPLIANCE


Kymanox has a diverse background covering biotechnology, pharmaceuticals, medical devices, in vitro diagnostics, and combination products. Turnkey solutions are available to support your objectives as you progress from early stage clinical development through commercialization and post-commercialization. Our experts can support specific projects or augment staffing for defined periods of time. Kymanox helps eliminate the ambiguity surrounding regulations and published guidance to make end-requirements clear and concise. Once this clarity is established, interactions with the governing regulatory agencies can be efficient and productive. Kymanox operates effectively in both proactive and reactive situations. We have expertise in organizing data for regulatory review and assembling logical and thorough explanations on complex issues, including issues related to first-in-class products.


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FOUNDATION OF PROVEN PAST PERFORMANCE


The Quality + Compliance team at Kymanox is responsible for providing services to our clients at clinical and commercial stages in the following areas:


  • Quality Management System (QMS) Development and Improvement

  • Pre-Approval Inspection (PAI) Readiness

  • Quality Improvement Tool Implementation and Oversight

  • Risk-Based Quality Audit Program Development and Administration

  • Due Diligence Evaluations and For Cause Audits

  • Mock Regulatory Body Inspections

  • Supplier Qualification

  • Regulatory Submission Content Creation and Review (e.g., IND, NDA, BLA, PMA, 510k)

  • Gap Assessments with Standards and Regulations (e.g., FDA, EMA, ICH, ISO, USP, WHO)

  • Risk Management (e.g., Assessments, Analyses, Control Plans)

  • Aseptic Processing Guidance for Sterile Dosage Forms

  • Regulatory Strategy and Pathway Development

  • Design Control Implementation, including Design History File (DHF) Remediation

  • Verification and Validation (V&V) Master Planning

  • Regulatory Body Response and Remediation (e.g., 483s, Warning Letters, Consent Decrees, Recalls, Other Enforcement Actions)

  • Clinical Support (e.g., Clinical Evaluation Reports (CERs), Pharmacovigilance, Good Clinical Practice (GCP) Audits)

  • Regulatory Body Communications and Meetings (e.g., Type A/B/C Meetings, Pre-Subs, Briefing Booklets)

  • Complete CMC and Clinical Staffing Solutions and Access to Our 60+ Experts


quality management system oversight


  • Document Control

  • Batch Record Review and Release

  • Non-Conforming Products and Out-of-Specification Results

  • Deviations and Investigations

  • Corrective and Preventive Actions (CAPA)

  • Change Control

  • Complaint Handling

  • Safety Reporting

  • Post-Market Surveillance and Annual Product Review (APR)

  • Training Programs