Established in 1990 Clementi Associates Ltd. has provided high level consulting services to the drug 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 a regulated, and now a globally competitive industry with powerful digital tools to expedite filings. But interdisciplinary communication is key: regulatory strategies have to succeed at FDA and with Investor Groups. Our focus has been and remains on discovery translation to initial testing in man or simply the IND process. We help you manage the program to proof-of-concept.
- INDs for drugs and biologicals
- GAP Analyses to assess “readiness” pre-IND Type B meetings and/or IND enabling studies
- Orphan Drug Designations (Application & Life Cycle)
- Pediatric Drug Development (within Orphan Drug Development)
- Type B and C Meetings to Support IND Submissions
- Expanded Access Programs
- Evaluation for Product Specific Expedited Pathways
- Investigator Initiated INDs and University Initiated Studies
- Comprehensive Life Cycle Management of INDs and DMFs
- Complex and Time Sensitive eCTD and RPS Submissions for INDs
By turning our attention to these key areas we are able to work across many therapeutic areas and accordingly, work with many Divisions within CDER and CBER. This experience has allowed our clients to have successful meetings and submissions; create strategic plans, and optimize product maturation.