Medical and Regulatory Affairs Consulants.

Where Success Matters.
Experienced. Trusted. Dedicated.

CA web graphic 03Established in 1990 Clementi Associates Ltd. has provided high level consulting services to the drug and device industry during the evolving regulatory landscape.  We are at a time of true global drug development and registration.  Concurrently, manufacture sites are able to provide drug products to global communities.  Many more people are treated and exposed to drugs now more than ever before.  This combined with new regulatory paradigms are altering our approach to drug development.  It is more complicated with a lower margin of error.  It is a regulated, and now a globally competitive industry with powerful digital tools. Our focus has been and remains on the following key areas in new product development:

  • Type A, B and C Meetings
  • Orphan Drug Applications
  • Pediatric Drug Development
  • Complex and Time Sensitive eCTD and RPS Submissions
  • GAP Analyses for pre-IND and pre-NDA Filings

By turning our attention to these key areas we are able to work across many therapeutic areas and accordingly, work with many Divisions not only within CDER but CBER as well.  This experience has allowed our clients to have successful meetings and submissions; create realistic strategic plans, and achieve optimal efficiency within the product life cycle.