Established in 1984 as a regulatory consulting firm specializing in FDA submission, Applied Laboratories, Inc. has evolved into a full-service contract manufacturer organization. We are registered with the FDA as both a drug and medical device manufacturing site. Initial construction began in 1988 and facilities have grown to a current footprint of 200,000 sq-ft — designed to facilitate Good Manufacturing Practices (cGMPs) for pharmaceutical, medical device, and health care industries.
Staff is experienced in all phases of pharmaceutical and medical device manufacturing, packaging, and development. We assist our customers from the design concept to final marketed product distribution process. Applied Laboratories is dedicated to providing quality customer service and specializes in meeting client needs and timelines based on streamlined organizational structure and experienced, knowledgeable staff. We are committed our customers’ success with our sincere focus on superior customer and vendor communications.
Constant attention to regulatory issues and guidance keeps Applied current on FDA requirements and procedures. We are ready to provide assistance in NDA, ANDA, 510K, PMA, and other regulatory submissions and requirements.
Applied Laboratories is a manufacturer of trade and store brand over-the-counter (OTC) pharmaceutical and healthcare products. Our current product mix consists of liquids, cream, ointments, and gels in both standard packaging as well as unique, state-of-the-art packaging and delivery systems. Utilizing strong vendor relations, we continually seek to incorporate new, novel, and convenient delivery systems for both metered and continuous product delivery.