For developers using Synecta, BlueWhale Bio provides regulatory tools, including:

• Access to BlueWhale’s Drug Master File (DMF) to support new or amended IND submissions
• Early FDA engagement enabled by Synecta’s Advanced Manufacturing Technology (AMT) designation, helping establish clear and predictable expectations for new trials

Our customer support and regulatory teams work with partners to address questions and support decision-making, including planning and testing to inform comparative assessments, if needed.