Pharmaceutical Analysis
Drug development is more than just clinical trials. Our pharmaceutical analysis services provide support for your company at all stages of development, from preclinical decisions to post-market regulatory inquiries.
Pharmaceutical products are evaluated on two critical metrics: efficacy and safety. While these two measuring sticks guide your clinical trials and determine primary and secondary endpoints, you know there are many more metrics that contribute to successful drug development. The quality of raw materials, the particle size distribution of drug ingredients, and even the composition of a storage container can affect process outcomes. These data points may not make headlines, but they can make or break an application for marketing approval.
Gateway Analytical is a cGMP-compliant laboratory with ISO 9001 and ISO 17025 accreditations that provides industry-leading pharmaceutical analysis services tailored to support your unique drug development projects. Our FDA-inspected laboratories are licensed with the DEA to accept Controlled Substances (Schedules II, III, IV, V) and are even equipped to handle and isolate particulate from cytotoxic drug materials. And as the pioneer of Raman techniques for ingredient specific particle sizing, you can have full confidence that our innovative, forward-thinking experts will be ready to tackle your team’s toughest challenges.
Frequently Asked Questions
Early stages of risk can definitely be identified in your development process. Gateway Analytical offers several different analytical methods from visible to sub-visible particulate analyses, as well as Container Closure Integrity Testing to assist with any breaches in stoppered vials.
Yes! Gateway Analytical’s unique services provides supplemental data for IND, ANDA, and NDA filings. Gateway Analytical has helped several of their customers submit satisfactory filings to bring their product to the market.
Gateway Analytical has several methods to assist in product development of pharmaceutical materials. Gateway’s ability to perform CCIT analysis using the deterministic method following USP<1207>, gives our customers the ability to assess their manufacturing process from the beginning. Gateway Analytical also provides glass delamination testing in accordance to USP<1660> to assist in the determination of drug product and vial interaction. In conjunction with CCIT and glass delamination studies, Gateway Analytical has the capabilities to perform automated Raman analysis, as well as automated SEM-EDS to support the characterization and sizing of organic and inorganic sub-visible particulate.
Yes, Gateway Analytical performs USP<788> and USP<789> analyses to assist customers during stability testing of both injectable and ophthalmic solutions. The methods performed include light obscuration (HIAC) analysis and manual microscopy to count and size sub-visible particulate matter. Customers routinely send Gateway Analytical stability samples at various time points for the aforementioned methods. The data obtained allows customers to monitor their samples over the intended stability study, providing supplemental information regarding product shelf life/service life of components.
Gateway Analytical is a GDP laboratory in a state of the art facility that helps customers all over the world. All samples received at Gateway are handled in a secured manner and follow internal SOP’s to ensure sample integrity from start to finish. When samples are not actively being analyzed, they are kept in a secured storage location within the facility. All designated storage locations are temperature monitored by a qualified outside vendor and provide immediate notifications upon temperature excursions.
Our pharmaceutical analysis services support your drug development efforts and quality assurance programs from behind the scenes.
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