Success Stories

You Spoke, We Listened

Camargo is dedicated to continual customer satisfaction and taking the steps to ensure the best possible service is provided. Camargo recently surveyed several clients to find out how they felt about the drug development services provided to them. The results are in!

Testimonials

"They are a respected partner who will give feedback on whether a concept is good or not, what the markets are [for the product], and strategic feedback right from the beginning."

"Everyone wants it faster. But the high quality—can they deliver? Camargo does."

"Camargo gave us a lot of answers and held our hands and made us feel like a good customer of theirs, even though we're small. They took us seriously."

"All our needs are outsourced; we do not have facilities, so work is carried out through contractors—(Camargo has) everything needed related to pharma development."

"We're among the mid-sized pharma sector and are moving fast in proprietary research based on our own pharmacology and toxicology background. We don't have qualified people to do CRO work and studies, so we hired Camargo."

 "A specialty drug development firm with a specialization in areas that others don't have (women's health, contraceptives, HRT-type development. They know 505 (b)(2) extremely well."

FDA Insight – Case Study

In 2007 Camargo was retained by a client to determine the regulatory status of ORUDIS tablets. Camargo presented the FDA with a citizen petition with relevant arguments for assertion that the product was not withdrawn for safety or efficacy reasons.  The FDA reviewed the information as well as its independent investigation and made the determination in the client's favor.

Determination That ORUDIS KT (Ketoprofen) Tablets, 12.5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary: The Food and Drug Administration (FDA) determined that ORUDIS KT (ketoprofen) tablets, 12.5 milligrams (mg), were not withdrawn from sales for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ketoprofen tablets, 12.5 mg.

Food and Drug Administration. (2007, August 14). Determination That ORUDIS KT (Ketoprofen) Tablets, 12.5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register [Newsletter], p.45434, Vol. 72, No. 156.