I your company growing? Having a few QA-related "growing pains"? Have you begun production but not yet commercialized your product? Have you developed marketing materials but not yet begun product distribution or sale of services? I will help you establish controls for critical production and service records, including those for contract manufacturers, design and development change management, product identification and traceability, tracking systems for corrective actions, customer complaints and field actions. If applicable, I will help guide you through product and process revalidation and regulatory submission efforts, including clinical studies and third party compliance testing.. During development of user instructions and other labeling, including marketing materials, I will assist with compliance reviews.