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Information about outsourcing services that may be useful in research and development or manufacturing. Content is provided by companies, with no preference intended. 24 OctOber 2018 Inhalation Testing services to support development Gateway Analytical strives to support foreign particulate characterization investigations and API sizing, counting and identification studies during drug development and manufacturing processes. Our unique forensic-based testing methods allow us to support pharmaceutical issues faster, producing results in as little as 24 hours from sample receipt. We are FDA registered, cGMP complaint, DEA licensed and ISO 17025 certified. We ensure that all testing is performed to provide results efficiently and effectively, while maintaining the highest quality standards. Gateway Analytical US: +1 724 443-1900 Partnering to meeting FDA reliability expectations Next Breath is a full-ser- vice cGMP compliant laboratory specializing in the analytical testing of drug delivery systems. We provide guidance and support for under- standing the expecta- tions for new combina- tion drug products. To meet the needs of new FDA Combination Product Guidelines, we offer extensive services to test actuation force, reliability studies, in-use studies, and performance during shipping. Our team of dedicated scientists can help you navigate these distinct expectations, even during investigational new drug applications. Next Breath US: +1 410 455-5904 Development of inhalation and nasal drug products Catalent Pharma Solutions can partner with you in all stages of development for inhalation and nasal drug products. Catalent's experience and expertise can sup- port you across a broad spectrum of services from method development to particle engineering to spray pattern evaluations. In addition, Catalent provides the know-how and capability for clinical and commercial manufacturing. Our inhalation services have a track record of excellence and we routinely develop and sup- port the commercialization of nebules, pMDIs, DPIs and nasal formulations for clients around the globe. Catalent US: + 1 888 SOLUTION Bringing products from concept to market Strong bio-performance of your inhaled therapeutics is key to realizing optimal patient outcomes. Lonza sup- ports you in optimizing performance, leveraging unique capabilities and expertise in product design and particle engineering. You gain access to a large array of special- ized tools, including micronization, spray dry process- ing and nanocrystal technologies. Combined with for- mulation expertise for both small and large molecules, specialized DPI capsules, and finished product manu- facturing capabilities to commercial scale, we bring your product from concept to market. Lonza US: +1 800 706-8655 ROW: +44 1506 448080 Special Section outSourcing ServiceS This section of Inhalation provides information that may be useful in research and development or manufacturing. Content is provided by the organizations listed. No endorsement or preference is intended.

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