Quality+ComplianceHeaderQuality Assurance and Regulatory Compliance

The Quality + Compliance team has a diverse background covering biotechnology, pharmaceuticals, medical devicesin vitro diagnostic devices, and combination products. Services are available to support our clients’ needs as they progress from early stage clinical development through commercialization and post-commercialization. Our experts can be used on a project-by-project basis or in staffing assignments for a defined period of time depending on need.

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 body review and assembling logical and thorough explanations on complex and involved issues, including issues related to first-in-class products.

Foundation of Proven Past Performance

The Quality + Compliance Team at Kymanox is responsible for providing services to our clients 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
    • Mock Regulatory Body Inspections
    • For Cause
    • Supplier Qualification
    • Clinical or Commercial Facilities
  • Good Clinical Practice (GCP) Compliance
  • Regulatory Submission Content Creation (e.g., IND, NDA, BLA, PMA, 510k, Design Dossier)
  • Gap Assessments with Standards and Regulations (e.g., FDA, EMA, ICH, ISO, USP, WHO)
  • Risk Management (Assessments, Analyses, and Control Plans)
  • Aseptic Processing Guidance for Sterile Dosage Forms
  • Regulatory Strategy Development for Drugs, Biological Products, Medical Devices, and Combination Products
  • Medical Device and Combination Product design controls implementation
  • Medical Device and Combination Product Design History File (DHF) or Technical File creation and remediation
  • Verification and Validation (V&V) Master Planning
  • Regulatory Body Response and Remediation (e.g., 483s, Warning Letters, Consent Decrees, Recalls, Other Enforcement Actions)
  • Virtual Quality and Regulatory Compliance Staffing Solutions and Access to Our 60+ experts
  • QMS Oversight including:
    • Corrective and Preventive Actions (CAPA)
    • Non-Conforming Products or Out-of-Specification Results
    • Deviations
    • Root Cause Investigations
    • Risk Management
    • Change Control
    • Complaint Handling
    • Training Programs
    • Post-Market Surveillance
Minimize Setbacks

With Kymanox involved early on, Quality Assurance and Regulatory Compliance will have the proper direction and resources to be proactive rather than reactive.  Early engagement helps avoid a majority of potential issues that may impact the overall development and commercialization program, product quality, or most importantly, patient safety.

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