Services Offered
An effective and efficient tool for the product approval
Regulatory Strategy plays a critical role in the quick, effective and efficient approval of pharmaceutical products. Axiona solutions is able to provide a wealth of experience in dealing directly with Regulatory Agencies, requesting Scientific Advice and liaising with Subject Matter Experts and Advisory Committees.
• Risk Management Planning
• Response to agency queries
• Agency meetings
• Advisory Committee preparation
• Scientific Advice
• Guideline and Protocol Assistance
• Lifecycle management