Material compatibility assessment for prefilled syringes, cartridges, and vial systems, including extractables/leachables studies (ISO 10993-18), container closure integrity testing (USP <1207>), and accelerated stability protocols.

Protective packaging engineering for autoinjectors, combination kits, and temperature-sensitive biologics, with distribution simulation testing (ISTA protocols) validating performance through shipping, storage, and patient handling

ISO 11607 packaging validation for sterile devices and combination products, including seal strength testing, microbial ingress studies, and aging protocols that withstand FDA/Notified Body inspection.

FDA UDI requirements (21 CFR Part 801), EU MDR UDI-DI/UDI-PI implementation, and DSCSA serialization for combination products navigating both pharma and device tracking requirements