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How do you make better development decisions faster?

Pharmaceuticals

How do I ensure the proposed study will adequately inform my next development decision? How do I know what E&L data the FDA will require? How can I ensure supplier changes don’t impact quality? For more than two decades, EAG scientists have been helping the pharmaceutical industry solve problems like these. Through multidisciplinary science and engineering, we improve product development efficiency and expedite time-to-to market.

Product Innovation & Improvement

EAG scientists support new product development, reformulation and lifecycle initiatives with primary research and exploratory studies, a broad array of GLP and cGMP-compliant analytical services, and drug and device development expertise. Whether we’re developing a complex analytical method or cell-based bioassay, characterizing intermediate materials or performing routine sample testing, you can count on EAG to deliver well-thought out study designs, reliable data, expert interpretation and rigorous regulatory compliance.

Investigation & Troubleshooting

When things don’t go as expected, it is critical to have solid science on your side, and the response must be specific and disciplined. EAG has decades of experience investigating issues related to supply chain inputs, process and product failures, packaging and other sources of contamination. Our scientists are experts at developing innovative test designs to troubleshoot problems across all major dosage forms and delivery systems—from coated tablets to unit dose vials (UDVs) and metered dose inhalers (MDIs). EAG offers deep expertise in the isolation, elucidation, identification and characterization of trace levels of knowns and unknowns for both regulated and non-regulated studies.

Quality Assurance

EAG supports quality assurance and quality control initiatives with independent stability and release testing, certificates of analysis for drug and drug product, and third party verification for supply chain inputs, components and packaging.  From compliance with the latest USP <232/2232> guidance on trace elemental analysis to routine stability and QC release testing, EAG is here for you.

Regulatory Compliance

EAG scientists have the experience required to translate guidelines into study designs that deliver the specific, reliable data that regulators expect. This not only helps you avoid unexpected delays and related costs, it helps to efficiently progress programs to their next development milestone.  All regulated studies are conducted under strict compliance with Good Laboratory Practice or Current Good Manufacturing Practice guidelines. EAG has a stellar FDA inspection history, including an unblemished track record for successful FDA pre-approval inspections.

Manufacturing & Supply Chain Support

EAG offers comprehensive CMC analytical support and quality control for API and drug product for all dosage forms, performed under phase-appropriate CGMP.  Areas of particular expertise include extractables and leachables programs, container-closure systems selection and qualification, and the development, validation and analysis of process, product and host cell protein impurities to support biopharmaceutical stability programs, forced degradation studies, and product and process investigations.

Consulting/Litigation

EAG’s experience extends beyond the laboratory and into the court room. We maintain a team of litigation experts who regularly assist clients with trial preparation, depositions and expert witness testimony. EAG scientists have extensive experience supporting cases involving intellectual property, product liability and insurance claims, as well as evaluating the scientific validity of academic publications, media reports and other claims for government institutions and private industry.