A flexible approach to clinical trial services for steriles

Our team of experienced development scientists formulates and produces required quantities of clinical trial materials for all stages of your molecule’s clinical development plan. We provide fit for purpose formulations for all clinical phases and a comprehensive range of sterile injectable dosage forms. From simplified dosage forms in the earliest clinical stages to critical registration batches, our scientists optimize your formulation with your long-term goals in mind. This can allow us to scale your product seamlessly through later phases of development and ultimately to commercialization. Our Quick to Clinic™ programs rapidly accelerate your molecule to first in human (FIH) studies using minimal amounts of your valuable drug substance.

Reliable Clinical Trial Materials

Clinical trial material in general can have unique needs. These include the need to:

  • Minimize the loss of expensive product
  • Reduce variability and risk through quality driven, global, automated processes
  • Minimize the “time out of environment” (TOE)
  • Eliminate costly bottlenecks and deliver efficiency

Pre-filled syringes and cartridges, in particular can have additional requirements to support clinical trials.  With speed, flexibility and a full range of services, we will can respond to your requirements and evolving needs as your project progresses through clinical trials. Our special services for pre-filled syringes and cartridges include:

  • Plunger, backstop, and needle safety device assembly
  • Precision primary labeling
  • Single and multi-pack secondary packaging and labeling
  • Assembly and labeling at ambient and refrigerated conditions
  • Pre-filled syringe and cartridge blinding
  • Cold chain storage and logistics

Download our Whitepaper: Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs