Since 1990, we have focused solely on medical and regulatory affairs including drug and device submissions, content reviews and risk
assessments. We are committed to understanding reform of the FD&C Act, PDUFA, FDAAA, and assessing the impact reform will have on drug development and commercialization.
Since 1990, we have focused solely on medical and regulatory affairs including drug and device submissions, content reviews and risk
assessments. We are committed to understanding reform of the FD&C Act, PDUFA, FDAAA, and assessing the impact reform will have on drug development and commercialization.
assessments. We are committed to understanding reform of the FD&C Act, PDUFA, FDAAA, and assessing the impact reform will have on drug development and commercialization.
Clementi Associates is a full service provider of global regulatory and medical services, working with the small to medium size company to transform good science into medically useful and commercially viable new products.
Clementi Associates is committed to mastering the new demands of medical and regulatory affairs in a rapidly evolving drug and medical device industry. Procedural changes at the FDA, the impact of FDAAA, for example, present an opportunity for faster drug approvals. Proactive compliance to post-approval guidelines and REMS, 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.