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.

Understanding where our services are desired and made most effective is our #1 priority. Download our Pharmaceutical Analysis Process Poster today to learn more.
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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.

Patients rely on your product to improve their daily lives.

You can rely on Gateway Analytical to ensure your product delivers

Frequently Asked Questions

Q:

Will early stages of risk be identified in our development process?

A:

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.
Q:

Does your research support Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) filings?

A:

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.
Q:

Does your product development provide how pharmaceutical materials, their compatibility, physical properties and stability are integrated?

A:

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.
Q:

Will the findings provide information on shelf life or service life of components?

A:

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.
Q:

What measures does Gateway Analytical take to ensure stability in testing and temperature cycling?

A:

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.

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.

Ever wonder about a foreign material in your product? We can tell you what, how, and why.

Skip the clinical trials and catch your competitors with our spectral and elemental analysis techniques.

Interactions between a glass container and your product can make all the difference in quality.

Confocal Raman Microscopy Particulate contamination in pharmaceuticals and medical devices can greatly impact product quality, production efficiency, and brand reputation. It is critical to analyze samples and mitigate the risk before your product goes to market.

We have a unique expertise in API specific particle sizing, built on longstanding relationships with generic drug developers.

The acidity and basicity of your product can affect its shelf life and container.

We’ll help you get to know the particle population in your liquid or inhaled product.

Don’t allow your drug development efforts to be sidelined by surprise changes in formulation.

The output is only as good as the inputs. Work with us to identify the best starting materials.

We can tell you how and why surfaces break down, then help you develop a solution.

We offer traditional and orthogonal approaches to the detection and identification of particles in injections and ophthalmic solutions.

Knowing what is only half the battle. We help you find where a contaminant originates.

Specialty Areas of Expertise: • CCI using the CO2 overpressure vessel and CO2 analyzer.• CCI for lyophilized products packaged under vacuum.• CCI for products stored on dry ice.• CCI for products stored in the vapor phase above liquid nitrogen.• CCI for products purged with an inert gas at one atmosphere of total pressure.

We offer traditional and orthogonal approaches to the detection and identification of particles in injections and ophthalmic solutions.

Cell & Gene Therapy Product Characterization are a class of therapeutic drugs requiring special attention and understanding when it comes to the presence and characterization of visible and sub-visible particulate matter.