Protecting Patient Health
Extractables and leachables (E&L) studies are centered on identifying potential chemical compounds that could transfer from a drug product into the environment or directly affect patients. These studies are essential for safeguarding both environmental and patient safety, ensuring your products reach the the highest standard of quality on your journey to market.
Gateway Analytical provides robust E&L solutions to ensure the rigorous standards of quality and safety for a variety of healthcare products. Our services range from impurity identification, method development and validation, to materials characterization, and regulatory support; providing integral services for pharmaceutical companies and medical institutions around the world.
Your Partners in
Advanced Testing Solutions
At Gateway Analytical, our analytical experts are dedicated to guiding you through every step of your market journey. From comprehensive testing services to insightful regulatory consulting, we’re here to help you maneuver the intricate world of analytical testing and FDA compliance.
Pharmaceutical drug product development is more than just clinical trials.
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.
Our pharmaceutical analysis services provide support for your company at all stages of development, from preclinical decisions to post-market regulatory inquiries.
At Gateway Analytical, we pride ourselves on our 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 we are even equipped to handle and isolate particulate from cytotoxic drug materials. With Gateway Analytical, you can have full confidence that our experts will be ready to tackle your team’s toughest challenges.
Frequently Asked Questions:
Dig into the details for our expansive pharmaceutical analysis services listings and learn why we’re the industry’s partner of choice. Customized solutions are only a few steps away.
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 information to inform 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.
