Since 1990, we have focused solely on regulatory affairs including drug and device submissions, content reviews and risk assessments. We are committed to understanding reform of the FD&C Act, and assessing the impact reform will have on drug development.
Since 1990, we have focused solely on regulatory affairs including drug and device submissions, content reviews and risk assessments. We are committed to understanding reform of the FD&C Act, and assessing the impact reform will have on drug development.
Clementi Associates is a full service provider of global regulatory services (content and format reviews) working with the small to medium size company to transform good science into medically useful and commercially viable new products.
“R&D burn is constant, time lost is money lost!”
Clementi Associates is committed to mastering the new demands of regulatory affairs in a rapidly evolving drug and medical device industry. Procedural changes at the FDA, the impact of PDUFA, for example, present an opportunity for faster drug approvals. Awareness of new FDA regulations and their impact on drug development are necessary for a company to achieve successful submissions. In the clinical phase this avoids clinical holds; and in the application stage, this results in first-pass approvals.