How to deliver high quality clinical trial materials at any phase for regulatory approval.
Optimize your chances for approval
Formulating and producing the required quantities of clinical trial materials for all stages of your molecule’s clinical development plan is critical to the success of your project. We provide formulation development for all clinical phases and a comprehensive range of sterile injectable dosage forms. This can allow us to scale your product seamlessly through later phases of development and ultimately to commercialization. Our robust clinical solutions include will help you:
- 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 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
Our Quick to Clinic™ programs rapidly accelerate your molecule to first in human (FIH) studies using minimal amounts of your valuable drug substance.
