Drug Delivery Device Regulatory And Quality Services

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