One of our clients, a supplier of components to the pharmaceutical industry, required a drug master file. Working closely with the client, we scouted out a strategy, developed the data, wrote the master file, and represented our client's interests to the FDA. Client product was accepted by the FDA-regulated industry and enjoyed a measurable increase in sales. When a manufacturer of a medical instrument was preparing for their pre-approval inspection, we supplied: An independent audit of technical reports Validation of process and methodology Mock inspection Staff support to address deficiencies The FDA inspection identified only a few, minor deficiencies that were easily corrected. A manufacturer of a medical device learned from a supplier that the plastic film used to manufacture the primary container would no longer be available. To help find an acceptable alternative, we provided technical regulatory services including: Evaluation of alternate polymeric films for tensile strength and oxygen permeability Protocols for seal strength and gamma irradiation degradation Validation requirements Manufacturing output was unaffected by this significant change. An international client wanted U.S. marketing approval for their product. We acted as the authorized representative to the FDA and helped guide our client's product through the approval process. A product developed entirely in Europe found The Market and a home in the Golden Land Of Opportunity.