Lyophilization Services of New England (LSNE), a leading contract development and manufacturing organization (CDMO) specializing in pharmaceuticals and medical devices, announced that it has received Good Manufacturing Practices (GMP) certification from Brazil’s National Health Surveillance Agency – ANVISA (Agência Nacional de Vigilância Sanitária) following an inspection and audit of its manufacturing facility in Manchester, NH in February 2019. This now allows LSNE’s clients to export medical devices to Brazil and is the first LSNE manufacturing facility to receive ANVISA certification.
Brazil’s GMP regulations, which closely resemble the internationally recognized ISO 13485 standard, require medical device manufacturers to have a robust quality system for the design, manufacture, packaging, labeling and storage of their products, among other requirements.
“LSNE is very pleased with the successful completion of the ANVISA inspection and GMP certification of our Manchester Medical Device manufacturing facility. Our strict adherence to GMP and our quality systems allows LSNE to provide our clients with a high quality product on time,” said Matthew Halvorsen, Chief Executive Officer, Founder and President of LSNE. “Our certification from ANVISA, represents an important milestone in being a premier CDMO and our continued commitment to quality and patient safety.”