Scientech Laboratories offers testing of pharmaceutical, medical device, and packaging materials to support your product safety and regulatory compliance needs. Our advanced analytical capabilities and experienced scientific team are equipped to help you:

• Assess potential Leachables from container-closure systems, medical devices, and drug-delivery systems

• Customize study designs based on your product type and risk level

• Proactively identify and address potential safety concerns before product launch

• Meet regulatory expectations from the FDA, EMA, and other global agencies

Scientech Laboratories has also implemented new testing standards USP <661.1> and <661.2> which allow for an initial risk assessment at a fraction of the cost and time than the previous USP <661> E&L requirements. This approach should reduce costs and timelines in most cases.

Scientech employs a wide array of advanced analytical techniques, including GC-MS, LC-MS, LC-MS/MS and ICP-MS to deliver accurate, compliant, and defensible data. Protect your products and your patients. Let us help you navigate the complexities of E&L testing. Schedule a consultation with our experts today at info@scientech-labs.com.

Scientech Laboratories has been family-owned and operated for 45 years, supporting the Pharmaceutical, OTC drug, Dietary Supplement, and Cosmetics industries with potency release testing, impurity profiling, heavy metals, nitrosamines, extractables & leachables, microbiology, stability studies and much more.

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