Gateway Analytical, a leading provider of innovative analytical testing and consulting services, is on the Contract Laboratory – The Laboratory Outsourcing Network. Known for their expertise in particulate analysis, forensic testing, and pharmaceutical services, Gateway Analytical delivers precise solutions that prioritize compliance and client satisfaction. Their addition strengthens the network’s ability to support businesses in highly regulated industries.
About Gateway Analytical
Gateway Analytical is an ISO/IEC 17025-accredited, DEA-licensed, cGMP-compliant laboratory with a strong reputation for providing accurate, high-quality testing and analysis. Their facility in Gibsonia, Pennsylvania, is equipped with advanced instrumentation and staffed by a team of highly skilled scientists dedicated to supporting pharmaceutical, medical device, forensic, and material science industries.
With a focus on compliance, Gateway Analytical adheres to the FDA, European Medicines Agency (EMA), Health Canada, and ICH guidelines ensuring reliable and regulatory-compliant results. Their tailored approach to client needs sets them apart, helping businesses address challenges efficiently and effectively.
Expert Services Provided
Pharmaceutical Services
Gateway Analytical specializes in comprehensive testing and analysis for the pharmaceutical industry. Their services include:
- Particulate Matter Identification (PMI): Using Raman spectroscopy, FTIR, and SEM-EDS (Scanning electron microscopy and energy dispersive X-ray spectroscopy), they analyze contaminants in injectable products to ensure safety and compliance.
- Glass Delamination Testing: Assessing glass vials for delamination risks to ensure the integrity of injectable drugs.
- Method Development and Validation: Creating robust analytical methods tailored to client needs while meeting regulatory standards.
Materials Characterization
Their materials characterization services offer a detailed analysis of physical and chemical properties of a range of materials. Techniques include:
- Morphological Analysis: Providing data on particle shape and size distribution.
- Elemental Composition Testing: Using SEM-EDS and XRF to analyze material composition.
- Thermal Analysis: Ensuring stability and performance under varying environmental conditions.
Forensic Testing
Gateway Analytical applies forensic techniques to industries such as law enforcement, insurance, and manufacturing. Their forensic services include:
- Gunshot Residue Analysis: Detecting and analyzing residue to support criminal investigations.
- Trace Evidence Analysis: Identifying and comparing fibers, glass, paint, and other microscopic evidence.
- Failure Analysis: Investigating material or product failures to determine root causes.
Microbial Identification
For highly regulated industries, this third-party testing laboratory provides microbial identification services to ensure safety and compliance. Using advanced molecular and biochemical techniques, they identify contaminants in pharmaceuticals, medical devices, and manufacturing environments.
Contamination Control
Gateway excels in contamination control for industries like pharmaceuticals and medical devices. Their services include:
- Environmental Monitoring: Detecting contaminants, extractables, and leachables in manufacturing facilities.
- Root Cause Analysis: Identifying sources of contamination to implement effective corrective actions.
Training and Consulting
Gateway Analytical also offers specialized training and consulting services for companies seeking to enhance their quality assurance practices. Their workshops cover topics such as:
- Contamination control strategies
- Advanced particulate matter analysis
- Forensic methodologies for industry applications
Why Choose Gateway Analytical?
Gateway Analytical is more than a testing laboratory; they are a trusted partner in quality assurance and regulatory compliance. Key reasons to choose their services include:
- Specialized expertise: A team of highly skilled scientists with extensive industry knowledge.
- Advanced techniques: They employ state-of-the-art instrumentation like Raman spectroscopy and SEM-EDS.
- Client-Centric Approach: Tailored solutions to address specific business challenges.
- Regulatory Compliance: Operating under stringent FDA, EMA, and ICH guidelines.
If you’d like to outsource your laboratory testing to Gateway Analytical, simply submit a test request and their team will get back to you at the earliest.
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