Nt Cmc Regulatory Consulting

Specializing in helping small to mid-sized domestic and international companies with the preparation of all necessary regulatory documentation to bring their FDA regulated products to market. Working on regulatory submissions and designing regulatory strategies on a broad spectrum of regulated products. Focused on the CMC part of the regulatory dossier, including Manufacturing and Design Control documentation, Product Composition, Design and Specifications, Environmental Assessment, Stability Studies, Control Strategies, etc. Working with a variety of technical documentation related to the development, manufacture, and testing of various complex products, conducting independent research as needed to enable the writing of summary sections for regulatory submissions. Drafting, reviewing, editing, and compiling submission documents and providing regulatory input into change controls, CAPAs, NCRs; assessment of the regulatory impact of changes in product specifications, manufacturing process, labeling to ensure compliance with FDA and international government requirements, including compliance with cGMP. Specializing in product development support for medical device and diagnostic companies consistent with ISO 13485 and 21CFR820, manufacturing, assembly, packaging and testing services; analytical methodology validations/verifications (ICH Guidelines) and process validation protocols and reports. Supporting audits/inspections to ensure full compliance for US audits/inspections of external manufacturing sites.