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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 — contact us today.

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.

Foreign Particulate & Contamination Analysis
Foreign Particulate & Contamination Analysis

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

Bioequivalence
Bioequivalence Studies to Aid FDA Approval

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

Glass Delamination
Glass Delamination Analysis - Testing Interactions in Drug Products

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

Foreign Particulate & Contamination Analysis
Confocal Raman Microscopy

It is critical to analyze samples and mitigate the risk before your product goes to market. Confocal Raman Microscopy is one of the testing approaches that can reveal the nature and distribution of contaminants in your biologics and small molecules. At Gateway Analytical, we have different instrumentation setups and inspection techniques that enable accurate analysis

Particle Size Distribution in Drug Products

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

pH Testing
pH Testing for Pharmaceutical Products

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

Particulate Sizing, Counting & Identification
Particle Sizing, Counting, And Identification for Pharmaceutical Products

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

Polymorph Identification
Polymorph Identification for Pharmaceuticals.

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

Raw Materials Analysis
Raw Materials Analysis for Pharmaceuticals

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

Surface Defect Analysis
Surface Defect Analysis for Pharmaceuticals

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

USP
USP <788> and USP <789>

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

Source Determination
Source Determination - Detect the Origins of Contaminants in Drug Products

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

S Forensics Ccit
Container Closure Integrity Testing (CCIT)

Testing of container closures is important as it ensures a sterile barrier against microorganisms and other potentially dangerous contaminants. Containers and closure systems receive testing of both primary, components that come into direct contact with a product, and secondary packaging components, those most important for ensuring the packaging is assembled correctly. Gateway Analytical Instrumentation LIGHTHOUSE’s

Antonio Scatena
Senior Sales Representative

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