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CTI Clinical Trial & Consulting Services is a full service provider of drug development, regulatory, consulting, healthcare communications, and continuing medical education services to the pharmaceutical, biotechnology and medical device industries. CTI offers complete clinical trial services for developing therapies that target the immune response with an emphasis on chronically and critically ill patients. CTI provides comprehensive services to facilitate smooth drug development and licensing, including managing all needed regulatory affairs and documentation. The firm ensures regulatory guidelines are being followed for clinical trials, quality assurance audits, and follow FDA and GCP guidelines clinical trial management. They develop regulatory documents and negotiate with regulatory agencies and serve as a regulatory agency liaison. CTI assists in regulatory document strategy, preparation and submission, trial design and regulatory strategy consultation, and product development pathway planning.