At Kymanox, our frequent interactions with regulatory authorities and our science-based expertise expedites Right-First-Time submissions for a broad range of biotech, pharmaceutical, medical device, and combination products. We emphasize a patient-centric, risk-based approach that successfully supports the introduction of first-in-class products.

We are experienced in the interpretation of applicable FDA and EMA regulations to ensure compliance, and we support efficient navigation through the multidimensional regulatory landscape. We interact on behalf of our clients with regulatory bodies and health authorities to lead various filing activities (e.g., IDE, PMA, IND, NDA, BLA) and to lead negotiations that resolve issues and respond effectively to 483s, Warning Letters, and Consent Decrees.

We provide Regulatory Affairs (RA) expertise and support in the following areas:

• Regulatory Strategy and Development Planning
  
  
• Regulatory Submissions and Agency Question Support
  
  
• Life-Cycle Management
  
  
• Quality Management System (QMS) Assessment
  
  
• CGMP and CGxP Compliance

• Chemistry, Manufacturing, and Controls (CMC)
  
  
• Clinical Trial Compliance
  
  
• Pre-Approval Inspection (PAI) Readiness
  
  
• Enforcement and Pharmacovigilance Remediation

Kymanox has scientific, technical, and regulatory expertise to ensure client projects are done Right First Time. Kymanox holds a 360º view of all regulatory compliance services and support these services with the following additional capabilities:

• Clinical and Medical Affairs
  
  
• CMC and Analytical Services
  
  
• Program and Project Management
  
  
• Quality Assurance, Quality Control, and Global Auditing
  
  
• Quality Engineering and Process Engineering
  
  
• Training
  

Biotechnology | Pharmaceuticals | Medical Devices | Combination Products