Chemistry, Manufacturing and Controls

Our team supports your chemistry, manufacturing and controls (CMC) development by:

• Identifying contract manufacturers specific to your needs.
• Managing the contract manufacturing and/or analytical testing of the drug substance and/or drug product.
• Providing regulatory guidance in setting appropriate manufacturing specifications, in method development and /validation and in conducting stability studies relevant to the clinical phase of development
• Consulting on GMP training and GMP feasibility audits, as well as producing standard operating procedure documentation writing
• Coordinating with contractors to ensure all development work is performed to your specifications and meets your timeline
• Preparing quality/CMC summaries for regulatory submissions