Biologics for US

• BLAs
• INDs
• DMFs
• Supplements to BLAs, DMFs
• Drug Product Listings
• Establishment Listings
• Preparation of facilities for Pre-Approval Inspections
• Assistance during the Inspection(s)
• Advice on how to handle changes to approved drugs
• Preparation of SOPs
• Assistance in Adverse Event reporting and recalls
• Annual reports
• Annual product reviews
• Internal Audits
• External Audits of contract manufacturers, components for container/closure, testing labs, sterilization facilities, etc.
• Technical advices on facility changes such as HVAC, testing equipment, sterilizer validation, equipment validation, stability programs
• Assistance in selection of contract manufacturers