CMC Maintenance & Quality Assurance

AssureImmune works with scientists and medical writing industry leaders, ensuring your Chemistry, Manufacturing and Controls (CMC) practices and specifications are complete, showing a comprehensive profile of your investigational product (IP).

Our wealth of information in cell therapeutics/biologics development and manufacturing is key in facilitating CMC regulatory approval, with our experts providing phase-appropriate technical expertise, including authoring, preparing, maintaining and updating your CMC.  

Partnering with you, we develop a strategy tailored to your specific needs. At each clinical phase and commercial launch, we ensure your IP meets the stringent FDA and global health authority regulatory compliance and quality standards.

AssureImmune offers the following CMC services:

• Preparing Regulatory Documents
• Reviewing & Maintaining Regulatory Documents
• Biologics Analytical & Formulation Development Programs
• Analytical Method Development & Process Validation Guidance
• Formulation & Process Development Guidance
• Clinical Trial Material Production Management
• Investigator Brochure Assistance
• Overall Regulatory Guidance