NanoClimate

​We can guide and assist in the CMC development including:

• CMC Strategies for Analytical Development, Drug Substances, and Drug Product Manufacturing
• Preparation of CMC regulatory submissions to US and International Agencies 
• Technical and Regulatory-Project Planning
• Technology Transfer and Process Validation
• Analytical Transfer and Validation
• Risk Based Approach for Development of Biologics and Biosimilars
• Stability Programs for Drug Substances and Drug Products

QUALITY ASSURANCE SUPPORT

We have the senior quality management experience to create effective quality systems and provide interim quality leadership. 

• CMO Selection, qualification, and monitoring via due diligence, qualification audits, quality agreements.
• Facility Design and Validation 
  
• Validation Master Plan Development
• Setting up and Monitoring Quality Systems in Compliance with cGxP Regulations
• Personnel Training
• Mock Pre-approval Inspections