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Analytical
We invest in the highest quality facilities and phase‑appropriate analytical capabilities to provide strategic value throughout the development and commercialization of your drug product. From raw material testing and method development to in-vitro bioequivalence (IVBE) functional performance studies, protein analytics, stability testing and regulatory support, we can turn your analytical obstacles into long‑term successes.
Analytical services: Designed with purpose
Discover an analytical testing approach defined by a desire to advance your product.
Method development and validation
Develop and validate robust analytical methods to ensure the quality and reliability of your drug product.
Raw material qualification
Ensure the safety and quality of your starting materials with comprehensive analyses, including USP compendial testing, tailored to your specific product and concerns.
Stability testing and storage
Conduct stability studies to assess long‑term drug product performance under varied conditions, supported by protein testing for biologics and predictive CFD modelling to identify early design risks.
Extractables and leachables testing
Identify and quantify extractables and leachables to ensure the safety and efficacy of your drug product.
Container closure integrity testing
Evaluate the integrity of container closure systems to maintain product quality and prevent contamination.
Elemental impurity control
Ensure compliance with ICH Q3D guidelines and USP standards through rigorous elemental impurity testing.
Innovative delivery formats
Our comprehensive analytical chemistry and testing services and our expertise in combination product development and manufacturing help ensure optimal outcomes across a wide range of delivery platforms.
As pioneers in respiratory drug delivery and inventors of the first pMDI, we offer comprehensive inhalation analytical services spanning in-vitro bioequivalence (IVBE), clinical phase development testing and lifecycle management for next-generation propellants supported by computational fluid dynamics (CFD) modelling.
Leverage our proven track record of regulatory approvals in the U.S. and European markets to optimize your nasal product’s analytical strategy, including CFD-based spray performance simulation to refine early development decisions.
Navigate the complexities of the injectable drug delivery market with comprehensive analytical roadmaps, including cGMP-compliant functional performance testing of autoinjectors and syringes, ensuring quality and regulatory compliance.
Comprehensive analytical services for both transdermal and intradermal drug delivery, including emerging formats like microneedle array patches, leveraging decades of experience and cutting‑edge technology.
Related CDMO solutions
Development
Our expert team collaborates with you, leveraging a development-by-design approach to optimize drug formulations and innovative delivery devices.
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Manufacturing
Discover scalable manufacturing solutions, from clinical trial supplies to commercial production, and state-of-the-art manufacturing facilities.
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Fill finish
Optimize your drug product fill finish with our state-of-the-art facility featuring high-speed, Annex 1-compliant lines for vials, cartridges and syringes.
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Regulatory
Leverage comprehensive support to confidently navigate the global regulatory landscape, ensuring compliance with FDA, EMA and other international standards.
Learn moreAnalytical resources and insights
Explore our library of resources to learn more about our comprehensive analytical testing capabilities and expertise.
Analytical testing strategy and approach for combination products
Download Kindeva’s presentation from the Pharma Ed Combination Products Summit for insights on how to ensure your combination product’s compliance with regulatory requirements through analytical testing.
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Your analytical services partner
Support your combination product throughout its life cycle with expert analytical services from Kindeva Drug Delivery. Backed by over a century of combination product expertise, we have unrivaled know-how to ensure your therapy’s compliance and quality. Discover our wide range of analytical services, including: Analytical method development & validation Stability testing & storage Extractables and […]
Learn MoreLet’s transform tomorrow together
Every patient deserves a brighter tomorrow. As your strategic partner, we are dedicated to building your lasting legacy and helping you fast-track healthier tomorrows. You dream it, we deliver it.