Drug Delivery Device Regulatory And Quality Services
Drug Delivery Device Quality, Without Compromise
Adapt processes while integrating systems and practices to provide traceability and documentation – required for compliance and regulatory approval and drug master files – to your external requirements. With full quality management processes from supplier controls through finished product complaint handling, Phillips-Medisize features a quality system, which is adaptable to global requirements and provides flexibility to customers.
A full range of services available to you, including product packaging and contract sterilization of finished devices built to your specifications and labeling that result in high-quality components and assemblies, on-time delivery, and the competitive pricing your program requires. We can provide full manufacturing services from concept through commercialization
At your service, our state-of-the-art facilities adhere to the following, rigorous quality standards:
- ISO 9001:2008, ISO 14001, and ISO 13485
- Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs) for 21CFR Part 210 and Part 211 Drug Packaging Requirements and FDA 21CFR Part 820 Quality System Regulations
- Ability to provide a full range of Phase I through Phase IV Product Development Capabilities, including design verification and clinical builds
- MHRA product certification
- MHLW device compliant
- CE marking
- RoHS-compliant manufacturing process
- UL CSA TUV certifications
- Certified class 7 (10,000) and 8 (100,000) clean rooms
- Support of class I, II, and III devices
A Note on Confidentiality: Your Technical information is Safe With Us
Steps we’ve taken to protect your data include:
- In-house tooling and design areas
- Secure shielded areas on the manufacturing floor
- Dedicated team members, including program managers
- Product traceability
- Secure data transfer and data storage