Accelerating the Future of Medicine
Precision Analytical Testing for Early-Phase Pharmaceuticals and Medical Devices
We know the journey from concept to market for pharmaceutical and medical device companies will be filled with challenges. That’s why we’ve crafted a range of service packages tailored to address every critical aspect. Our deep expertise in analytical testing and regulatory guidance makes us a reliable partner for companies aiming to achieve product safety, efficacy, and compliance.
At Gateway Analytical, we’re dedicated to helping companies around the globe navigate the early phases of pharmaceutical and medical product development with confidence.
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Empowering your journey from concept to market with tailored testing services, Gateway Analytical ensures your pharmaceutical and medical device innovations achieve global success with safety, efficacy, and compliance at the forefront.
Extractables & Leachables Study
Shipping Study (CCIT)
ISO 8871-3 Screening Verification (SVP)
Container Closure Integrity Testing (CCIT)
Glass Delamination Screening Verification
Residual Seal Force (Functional Testing)
The Container Closure System Testing Package is crucial for ensuring the integrity and safety of pharmaceutical packaging systems. This comprehensive suite of tests, including Extractables & Leachables Studies and Container Closure Integrity Testing, is designed to safeguard products against contamination and degradation, maintaining their efficacy throughout their shelf life. By evaluating the interaction between packaging materials and pharmaceutical products, this package addresses key regulatory requirements and consumer safety concerns, making it an essential step in the journey of pharmaceutical products to market.
Residual Seal Force (Functional Testing)
Extractables & Leachables Study
Container Closure Integrity Testing (CCIT)
The Container Suitability & Integrity Testing Package plays a pivotal role in the pharmaceutical and medical device industries by ensuring that packaging materials are compatible with the product they contain and maintain their integrity under various conditions. Through services such as Extractable & Leachable Studies and V/SVP Rinse Studies, this package helps in identifying potential risks and ensuring product stability, which is critical for gaining regulatory approval and ensuring patient safety.Â
Reference Materials Characterization
Reference Material
Database Creation
Visible & Subvisible Particulate Matter Analysis
Cloud-Based Particle Library
Our Visual Inspection Lifecycle Testing Package is integral to maintaining the highest standards of quality and safety in pharmaceutical manufacturing. By offering services like Reference Materials Characterization and V/SVP Rinse Studies, this package ensures the accuracy and reliability of visual inspections, a key quality control step. In an industry where the smallest impurity can have significant implications, this package underscores Gateway’s dedication to precision and excellence, facilitating a smooth transition of products from development to market readiness.
Extractables & Leachables
Visible & Subvisible Particulate Matter Analysis
Our Materials Technology Safety Testing Package addresses the critical need for comprehensive material safety analysis in the development of pharmaceutical and medical devices. With services like our Extractable & Leachable Study, it ensures that materials used in product packaging do not compromise product integrity or patient safety. This package reflects Gateway’s expertise in materials science and its application in enhancing product quality and compliance, essential for successful market entry and consumer trust.
Glass Delamination Accelerated Stress Tests
Stability Storage Comprehensive Testing
Our Container Compatibility Safety Study is designed to ensure that pharmaceutical products and their packaging are mutually compatible and safe over their intended shelf life. Services such as Glass Delamination Accelerated Stress Tests and Stability Storage are key to preventing product contamination and preserving efficacy, directly impacting product approval and market success. This package exemplifies Gateway’s holistic approach to product safety and longevity, supporting clients through the critical stages of product validation and regulatory scrutiny.
Regulatory Planning & Consulting
Documentation and Submission Support
Our Regulatory Support Package for Early-Phase Development is tailor-made to guide pharmaceutical and medical device developers through the intricate regulatory landscape. This service is invaluable for ensuring that early-phase products meet stringent regulatory standards, facilitating a smoother approval process. Gateway’s expertise in regulatory affairs, combined with this comprehensive support package, empowers clients to navigate early development challenges effectively, laying a solid foundation for successful product commercialization and market introduction.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
Empowering Your Journey Toward Enhanced Patient Care
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.