How to deliver high quality clinical trial materials at any phase for regulatory approval.
Optimize your chances for approval
We provide high-quality clinical trial materials to support your pursuit of regulatory approval, offering fit-for-purpose formulations for Phase I and IIa studies, and a comprehensive range of finished dosage forms for Phase IIb and III studies. Our robust solutions enable:
- Speed with a broad range of phase-appropriate fill/finish equipment
- Minimal loss of expensive drug product
- Ease of scalability to from early development trials to commercial scale once approved
With speed, flexibility and a full range of services, we will be responsive to your changing requirements and evolving needs as your project progresses through clinical trials. We have experience with:
- Stainless steel and single-use manufacturing platforms
- Filling lines fitted with various dosing pumps including peristaltic and rotary piston pumps
- Filling of temperature and oxygen sensitive compounds
- Controlled temperature compounding and filling
- Low line loss filling equipment
- cGMP batch sizes from several 100 units to several 100,000 units
- Pre-filled syringe and cartridge assembly
- Cold chain storage and logistics
