DEVELOPMENT CAPABILITIES

STEP 1
Process Development & Technology Transfer
Development engineering teams lead all aspects of product development/transfers from the clinical study stage and manage projects throughout the development lifecycle, process validation & commercial launch.
STEP 2
Analytical & Microbiology Support
Dedicated multidisciplinary team to support all aspects of development from method development, method validation, sterility & bioburden along with our robust microbiology lab.
STEP 3
Stability & Regulatory Support
ICH Stability program to support semipermeable conditions. Regulatory team supports project throughout regulatory lifecycle.