Pharmaceutical Testing Services

Our clients develop safe, efficacious products with confidence thanks to Element’s Biologics and Advanced Therapy Medicinal Products (ATMPS) testing services.

Element's biosimilar testing services support every stage of development, providing expert analysis and regulatory guidance to streamline the 351(k) approval process and bring safe, effective biosimilars to market.

Element provides expert cell-based bioassay services, including potency testing, method validation, and regulatory support, helping biopharmaceutical companies streamline drug development and approval.

We can help you accelerate your gene therapy development while reducing costs and ensuring patient safety. Our gene therapy process development and analytical methods support helps you overcome development challenges and meet regulatory requirements faster. We integrate QC-centric method development with comprehensive analytical testing to streamline your path from discovery to manufacturing.

Element's industry-leading expertise, methods, and purpose-built laboratories help to guide a steady, efficient path through regulatory approval for monoclonal antibody (mAb) therapies, the fastest-expanding class of protein therapeutics.

Element's advanced technologies and understanding of biological chemistry will help you characterize and optimize your therapeutic peptide programs.

Element provides expert therapeutic protein analysis, offering tailored bioanalytical testing to support IND and BLA regulatory pathways. Our services optimize stability, purity, and efficacy for therapeutic proteins and enzymes.

Element provides California Prop 65 compliance testing for manufacturers and distributors, helping identify hazardous chemicals, assess exposure risks, and determine labeling obligations to meet regulatory requirements and reduce legal exposure.

Element provides specialized analytical testing services designed for CDMOs, offering flexible capacity, regulatory compliance, and advanced capabilities that enable successful client program delivery across all development phases.

Element's lab provides specialist microbiology testing services and quality control for drug products that support all phases of product and process development and help to maintain product integrity.

Element's CDMO services offer tailored drug discovery and development solutions, helping you reduce costs, accelerate timelines, and advance clinical trials with expert support at every stage.

ICH-compliant pharmaceutical and biologics stability and forced degradation testing with advanced analytics, specialized storage, and regulatory support—designed to reduce risk and support successful drug development and submissions.

As a premier provider of molecular studies and testing services, Element delivers accurate and reliable results. Our CLIA-certified reference molecular lab is trusted to provide comprehensive molecular characterization of isolates.

Element offers pharmaceutical reference standard management, delivering tailored characterization, validation, and storage solutions to meet regulatory requirements and enhance product quality for small molecules, biologics, and biosimilars.

Element offers pharmaceutical cleaning validation and verification services to help manufacturers meet regulatory requirements, prevent contamination, and streamline processes for safe and compliant drug production.

Element provides expert compendial testing services to help pharmaceutical and biotech companies meet global pharmacopeial standards, ensuring product quality, compliance, and market readiness.

Element provides expert testing and environmental monitoring services for sterile compounding facilities, addressing contamination risks and regulatory compliance while enabling you to focus on patient care.

Element offers tailored pharmaceutical environmental monitoring services, helping maintain cleanroom control and regulatory compliance while protecting product quality and patient safety.

Element provides tailored extractables and leachables testing (E&L) studies to ensure patient safety and compliance with regulatory requirements.

Comprehensive GMP lot release testing services for pharmaceutical and biologic products. Expert scientists, advanced labs, and tailored solutions to meet rigorous quality and compliance standards globally.

Our material testing laboratories provide a complete suite of material testing services for pharmaceutical companies.

Element's Nuclear Magnetic Resonance (NMR) Spectroscopy analysis supports critical stages of pharmaceutical development, enabling verification of chemical synthesis and compound characterization.

Element's chemical characterization services help identify, analyze, and ensure the quality of materials, addressing challenges in purity, composition, and contaminants with advanced techniques and expertise.

Element's experts provide specialist particle analysis services for Particle Size Distribution (PSD) and particle counting following USP, EP, ASTM and ISO methods.

Our contamination detection and analysis services isolate and identify unknown particulates and contaminants in pharmaceuticals and biologics down to trace levels.

Element's pharmaceutical XRD testing delivers precise crystalline structure analysis with minimal sample requirements. Our advanced equipment and 30+ years of expertise help you meet regulatory requirements faster. Contact our experts today.

Element offers tailored rubber, polymer, and plastic testing services, supporting quality control, failure analysis, and product development with advanced techniques and expert insights for pharmaceuticals.

Element offers tailored rubber, polymer, and plastic testing services, supporting quality control, failure analysis, and product development with advanced techniques and expert insights for pharmaceuticals.

Our expert physical characterization scientists apply a variety of techniques, from SEM to TGA, to help you understand the physical properties of your pharmaceutical materials.

Element's solid-state characterization services streamline drug development, improving API performance, stability, and manufacturability. Our tailored strategies and expert teams address key pharmaceutical challenges for faster results.

With Element as your medical device testing partner, you’ll enjoy the benefit of a single comprehensive supplier across feasibility, R&D and prototype trials, through product development, regulatory validation and production quality control.

Successful FDA 510(k) submissions are critical to your market success. Incomplete or inaccurate submissions can lead to failure and may delay your product launch. Our Engaged Experts are ready to assist.

Element offers complete hand sanitizer efficacy testing, including USP 611 GC-FID and GC-MS methods, to verify alcohol content, purity, and safety, helping products meet regulatory standards.

Comprehensive medical grade polymer testing to support device development, improvement, and compliance with regulatory standards. Tailored solutions address safety, quality, and performance needs in medical devices.

Element's experts provide failure analysis of polymer-based medical devices, which is critical to ensuring that process or material improvements can be made to prevent repeated failures.

Element's regulatory and industry experts have a proven track record of successfully developing and validating fit-for-purpose, accurate, and reliable analytical methods based on established CDER/ICH and FDA guidelines and procedures.

Element provides reliable rapid mycoplasma and sterility testing and delivers results in a matter of days.

Element offers expert raw material and excipient testing services, addressing pharma industry challenges with advanced techniques to support quality, safety, and regulatory compliance throughout drug development and manufacturing.

Element provides professional testing services for containers, container closures, and pharmaceutical packaging on polymers and glass containers to several pharmacopeia methods.

SENTRY Antimicrobial Surveillance tracks global resistance patterns using advanced methods and a vast network of medical centers, supporting drug development and monitoring with over 20 years of expertise.

Element offers trace metal testing and impurity analysis services, addressing safety, compliance, and contamination challenges for pharmaceutical products with advanced techniques and global expertise.

Industry-leading elemental impurities testing for pharmaceuticals. Offering advanced methods, accurate trace detection, and regulatory expertise to support safe and compliant drug development processes.

Element offers expert impurity testing services for pharmaceuticals, ensuring drug safety, quality, and compliance with FDA and ICH guidelines through advanced analytical methods and tailored solutions.

Element offers advanced metal speciation analysis, providing detailed data on toxicity and bioavailability to support risk assessments in pharmaceuticals, biologics, and other industries.

Element provides expert testing services for USP 665, USP 1665, and BPOG standards, helping pharmaceutical companies manage compliance, safeguard patient safety, and speed up regulatory approval.

Element delivers GLP-compliant virology testing for antimicrobial products, helping companies meet global regulations, validate claims, and accelerate time to market with expert-led, reliable data.