Proven GMP Analytical Testing Services
Partner with our GMP analytical testing laboratories to leverage decades of experience and to achieve the requirements your program needs before progressing forward. Our full-service, extensive drug analysis capabilities combined with our experience and cutting-edge GMP, FDA-approved facilities provide important insights and documentation for approval and commercialization. You can access our secure laboratory data management system to streamline workflows and rapidly satisfy regulatory requirements.
Safeguard your drug product quality from setbacks/repercussions such as manufacturing delays and recalls with trusted raw materials data. Our raw materials quality control testing demonstrates the identity, purity, and quality of excipients and active pharmaceutical ingredients used in finished product manufacturing.
Maintain the highest quality standards with your products using our QC batch release testing, meticulous cleaning verification, and custom testing protocols for a wide range of molecule types. Our unwavering commitment to excellence ensures that your products are safe, efficacious, and ready to reach patients in need.
Leverage our comprehensive ICH stability testing services to ensure the efficacy and safety of your products throughout their shelf life. Our expansive storage chamber capacity accommodates a wide range of product types and packaging configurations, while our freeze-thaw cycling capabilities simulate real-world storage conditions for accurate stability assessments. Additionally, our photodegradation testing services help you determine the impact of light exposure on your products, safeguarding their integrity during storage and distribution.
Establish a reliable baseline for your analytical testing with credible reference standards verified by our team. We characterize, store, and distribute reference standards to support development and manufacturing processes so you can have confidence in your product’s purity, identity, and stability. We maintain secure and environmentally controlled storage facilities to ensure the integrity of your reference standards throughout their lifespan. And with our efficient distribution network, you can access your reference standards whenever and wherever you need them.
Demonstrate product safety and efficacy through our comprehensive extractables and leachables (E&L) testing. Our approach identifies and quantifies potential contaminants that could migrate from your packaging materials or implantable devices into your drug products. We perform chemical characterization of extractables by subjecting your product to worst-case conditions for constituent identification. Targeted leachables studies are then developed to specifically quantitate compounds of concern that were initially detected.
Verify the levels of elemental impurities in your raw materials, in-process formulations, and finished pharmaceutical and medical device products. Whether you need to demonstrate a level of control for regulatory compliance or monitor for a label-claim, our team has a wide range of experience using several instrumental techniques.
Safeguard the integrity and functionality of your pharmaceutical products through rigorous physical functional testing by our team. We perform container closure integrity to evaluate the packaging material’s ability to maintain product integrity and prevent environmental contamination. To gauge for accurate and convenient dosing to patients, we assess your drug products viscosity or syringability. As for packaging material strength and flexibility, our tensile elasticity testing measures the expected impacts upon shipping, handling, and storage. Additional unique physical or functional requirements can be addressed with custom method development and validation.
Ensure the safety and effectiveness of your pharmaceutical, biopharmaceutical, or medical device product with our reliable microbiological lab testing services. With a strong focus on GMP compliance and industry standards, we prioritize accuracy in every microbiology test we perform. Our experienced professionals offer tailored solutions aligned with USP/NF, EP, JP, and client-supplied methodologies, ensuring that your unique testing needs are met.
Assure your product’s quality and purity with comprehensive analytical method development and testing. We identify and characterize impurities for safety and purity. Your active ingredient content is precisely measured with validated analytical methods to ensure consistent dosing and therapeutic effect. In addition to quantitative tests, we offer qualitative limit tests to determine the presence or absence of specific impurities. Our team also applies activity assays and cleaning verifications as part of our analytical development and testing.
Our services are designed to deliver you with trusted data as seamlessly as possible, which is why our method tech transfers enable consistent and reliable results across different sites. We even proactively monitor and update analytical methods throughout the product lifecycle to remain fit-for-purpose and fully compliant with regulatory requirements.
PACKAGING
Performance testing of your product packaging is essential for the delivery of a safe and effective product. Our team provides a wide range of services evaluating the strength, integrity, materials, and labels of your packaging to ensure it satisfies key requirements.
STABILITY & STORAGE
Stability studies and shelf-life testing safeguards your products’ performance and regulatory compliance. We support studies for both short-term (accelerated) and long-term stability programs as well as photostability programs for both research and development and commercial products.
DISTRIBUTION
Distribution simulation testing provides a uniform and repeatable way of evaluating packaged products and packaging designs by utilizing standardized equipment and procedures to subject the packaging to anticipated hazards that may occur with routine distribution of packaged products.