Technical Transfer and Validation

Our comprehensive technical capabilities and deep appreciation of the procedures and protocols for transferring information between entities results in reduced errors and improved communications 

• Full oversight and ownership of process and analytical transfer to contract manufacturing sites.
• Due diligence and guidance on CMO selection for API and DP.
• Technical review of GMP documentation for manufacturing.
• Project timeline oversight and defining key milestones with potential road blocks for technical site transfers.
• Validation protocol drafting and oversight of validation studies at manufacturing sites.
• Specializations in API manufacturing, tablet formulations, and various aseptic manufactured drug products.
• Couple technical transfer activities with regulatory requirements.