Regulatory Consulting

LexaMed can assist in medical device and pharmaceutical regulatory compliance activities, including compliance and remediation action plans and strategies, assisting in new product submissions and regulatory registrations and conducting compliance audits per CFR 820, CFR 210/211, CFR 11, ISO 13485, ISO 17025 and Q7A

Our regulatory consultants can generate a Corrective Action Plan (CAP) in response to a FDA 483 report or Warning Letter.  The CAP will include:

• Compliance Action Plans
• CAP management
• Interacting with FDA
• Disciplined decision making and resource focusing
• Defining Key Performance Indicators (KPI)
• Managing organizational change
• Assessing CAPA effectiveness
• Establishing process capabilities
• Integrating program that will result in client internal sustainability

Experienced consultants can address situations with technically competent, proactive and comprehensive solutions in:

• Process Issues
• Sterilization Concerns
• Deficient Training Activities
• Insufficient Internal Audits and follow-ups
• Vendor Audit Issue
• Quality Management System Deficiencies
• Regulatory Affairs Issues