Pilot Phase and Clinical Trials Development Services
Drug Delivery Device Product Development Support Services
The pilot phases of a project present opportunities for enhancing speed-to-market, as well as cost efficiencies. How the end product will be manufactured, packaged, and assembled must be considered long before the first final product unit ever goes into production. Not considering design for manufacturing and automation early in the process can lead to complications and delays that can doom the project. Speed and efficiency during your program’s pilot phases and clinical trials are critical to your success.
We're committed to the quality systems management of your program from concept to commercialization, and during pilot phases and clinical trials. We will help you comply with drug and device regulations, as well as current Good Manufacturing Processes (cGMP) and Quality Systems (QS).
Quality Certifications and Compliance Capabilities
- Prior successful implementation and maintenance of applicable Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs), for 21CFR parts 210/211 drug packaging requirements and FDA 21 CFR Part 820 Quality System Regulations
- ISO 9001, 14001, and 13485
- Ability to provide a full range of Phase I through Phase IV product development capabilities, including design verification and clinical builds
- MHRA Product Certification (European)
- MHLW Device compliant (Japanese)
- CE Marking (93/42/EEC)
- RoHS-compliant manufacturing process
- UL CSA TUV certifications
- Certified Class 7 and 8 clean rooms
- Support of class I, II, and III devices