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All regulatory pathways are not the same.
Our team has many years of experience in the full spectrum of drug development—not to mention a thorough understanding of the FDA and its evolving standards.
If you have a drug that has been previously approved by the FDA and are looking to reposition it, then 505(b)(2) may be for you. These submissions have special requirements; our goal is to work with your team to develop a comprehensive program including a timeline with important milestones and costs. We manage every facet of the plan: formulate and test the drug product, conduct clinical studies and FDA application submissions.
Contact Camargo today at 513-618-0333 to find out if a 505(b)(2) is for you. | 
