Lyophilization Services of New England, Inc We are a premier contract manufacturer specializing in aseptic filling and lyophilization of both drug and medical device products. We provide creative solutions to your most demanding manufacturing challenges and timelines, while addressing quality and regulatory requirements essential to a fast and successful product launch. Strategically positioned to meet the industry need for all-inclusive preclinical to commercial stage manufacturing, our 3 integrated facilities incorporate 3 liquid fill lines, 20 lyophilization units ranging from 5 to 277 square feet, as well as analytical and support capabilities. The copmany offers a unique commitment to our clients, partnering with them to ensure we meet their goals and exceed their expectations! The company Passes Comprehensive FDA Inspection Manchester, NH – the copmany, a premier contract manufacturer specializing in aseptic fill/finish and lyophilization of both drug and medical device products, recently completed a week-long, comprehensive Food and Drug Administration (FDA) Audit of its medical device manufacturing facility. The successful completion of this audit for which no 483 citations were issued, demonstrates our continued commitment in offering its clients quality cGMP manufacturing services. The company has sustained positive corporate growth while maintaining the regulatory standards for both medical device and drug manufacturing; including the recent completion of an FDA Pre-Approval Inspection (PAI) and Compliance Audit for an Abbreviated New Drug Application (ANDA) for a sterile-injectable drug product at its Bedford, NH fill/finish facility.