Millennium Research Laboratories,

Millennium Research Laboratories (MRL), Inc. is a company dedicated to the pharmaceutical, biotechnology, and medical device industries. We provide a wide range of services including, but not limited to, technical consulting, analytical, and product development. MRL can help your business complete the goal of bringing new pharmaceuticals and biotechnological products to market with the full range of cGMP/GLP laboratory services. MRL was founded in 2002 by a group that possesses decades of combined experience in the fields of polymer science, advanced materials, drug discovery, and development. The laboratory facility is located in Woburn, MA. MRL offers a wide spectrum of services and expertise in scientific, professional, technical, manufacturing, quality control, and regulatory fields. Our services include formulation development, drug delivery design, analytical methods development, validation, and drug stability assessments; among other tasks. We can support your testing and development needs through the research, pre-clinical, and clinical phases. MRL works closely with our clients to provide quality on-time testing services to support New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug (IND), and Investigational Medical Product Dossier (IMPD) submissions. Some of our services include: • Cleaning Validation • USP/EP/JP Monograph, as well as AOAC testing • Dose formulation sample analysis • Excipient Testing • Extractable profile characterization • Controlled drug substances schedules II-V • Batch Record Review • Evaluation of Assay Data • Isolation and ID of Trace Impurities