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 — 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 - Gateway Analytical
Foreign Particulate & Contamination Analysis

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

Bioequivalence - Gateway Analytical
Bioequivalence Studies to Aid FDA Approval

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

Glass Delamination Analysis - Gateway Analytical
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 - Gateway Analytical
Confocal Raman Microscopy

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. Confocal Raman Microscopy is one of the testing approaches that can reveal the nature and distribution of contaminants in

Particle Size Distribution in Drug Products - Gateway Analytical
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 - Gateway Analytical
pH Testing for Pharmaceutical Products

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

Particulate Sizing, Counting & Identification - Gateway Analytical
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 - Gateway Analytical
Polymorph Identification for Pharmaceuticals

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

Raw Materials Analysis - Gateway Analytical
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 - Gateway Analytical
Surface Defect Analysis for Pharmaceuticals

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

Pharma USP 788-789 - Gateway Analytical
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 - Gateway Analytical
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.

Forensics - Container Closure Integrity Testing (CCIT) - Gateway Analytical
Container Closure Integrity Testing (CCIT)

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. Container Closure

Pharma USP 788-789 - Gateway Analytical
Particulate Matter Database

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

Cell & Gene Therapy Product Characterization

Cell & Gene Therapy Product Characterization Cell and gene therapy products 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. The presence and characterization of visible and sub-visible particulate matter in parenteral products is a critical consideration during development,