New technical experts 2025

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Suttons Creek Expands Technical Expertise to Support Growing Combination Product Demand As pharmaceutical and biologics companies continue to advance...
Case Study IND Rescue

Case Study IND Rescue

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Rescuing a Time-Critical IND Amendment for a Clinical-Stage Injectable Program Clinical-Stage Biopharma | Injectable Therapy in Prefilled Syringe  ...
Combination Product Business Case Template

Combination Product Business Case Template

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Developing an internal business case for a Combination Product When Pharma and Biotech leaders begin considering a delivery device for their...
Cross-Center Master Files

Cross-Center Master Files

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed FDA’s new draft guidance is providing clarity on cross-center master files FDA recently issued a new draft guidance titled Cross-Center Master...
EUDAMED is mandatory

EUDAMED is mandatory

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed EUDAMED will become mandatory for selected modules… Pharma/Biotech sponsors of co-packaged devices and other separately distributed devices...