Daelit

daelit is a consultancy serving the pharmaceutical and animal health industries. We provide advice and solutions to problems from the unique and unexpected to the everyday. daelit strives to help your organization rapidly and efficiently find your path forward. Our attention to detail, dedication to quality, and the importance we place on customer service ensures that we will be with you every step of the way. With our agile and motivated company structure, we are ready and willing to step in to handle any challenge your regulatory process presents you. Our consultants are on hand to help diagnose problems, develop solutions, and provide support for your regulatory needs. Compliance & Quality • Regulatory Strategy • Mock Inspections • Vendor Qualification • cGMP Audits • Labeling and Packaging Review • Marketing Materials Review: Print, Web,TV Regulatory Services • Establishment Registrations • Labeler Code Requests • FDA E-Submission • Agency Meeting Requests • CBE-0, CBE-30, MCSR Submisions Validation & Qualification • Process Validation • Facility Layout Review • Master Validation Plans • Process Flow Consulting