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Welcome to Product and Educational Services LLC ("PES") website. PES provides logistical product services to companies conducting clinical trials for their investigational new drugs (IND) and devices (IDE) and provides quality system consulting to pharmaceutical and medical device companies. PES is registered with the FDA as a manufacturer and has the capability and space to conduct manufacturing, relabeling, storage, handling, and distribution of their client’s property. PES’ strength is its knowledge and experience in ensuring compliance with applicable Good Clinical Practices (cGCP), Good Manufacturing Practices (cGMP), and Good Laboratory Practices (cGLP). PES customers can be assured that their investigational drugs or devices will be handled, stored, and shipped in a safe and secure manner according to approved procedures that comply with applicable FDA regulations. Product and Educational Services LLC (PES) has been in business since 1988 helping medical device and pharmaceutical companies establish and implement quality systems, validate software applications and embedded computer programs, writing and submitting 510k Premarket Notifications. Past and present client companies include Glaxco SmithKline, Pfizer, Cordis, Stryker, Gulden Ophthalmics, Peregrine Surgical, ElectroCore Medical Products, and Comprehensive Neuroscience Inc. |
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