A Targeted Approach
We are experienced drug development scientists who have focused on medical and regulatory affairs.
We have Therapeutic Competencies and Regulatory Competencies that are deeply rooted in science and supported by many years of clinical and basic science experience.
Getting Started with the FDA
*2 weeks prior to IND Submission for CBER
Demonstrated Competencies in 2018-2019
> 100 Submissions to CDER, CBER, CDRH, and CVM
IND Waiver for NIH Multi-center in Stroke Granted
Type A Meeting in GI Rare Disease–Agreed Path Forward—Phase 3 Study to Start
Full Clinical HOLD Removed in Less Than Three Months in ODE 1
Successful Index Eligibility in CVM and OMUMS Assembly of CVM QEP
Successful Type B Meetings in New Cell Therapies
I have worked with Dr. Clementi on a number of projects requiring consultation with the FDA and on each occasion his detailed knowledge of the process, the underlying science and his well-established rapport with senior staff in the agency always resulted in a successful outcome. Dr. Clementi facilitated all aspects of communication and meetings with the FDA making the whole process seamless. He is a pleasure to work with and I would highly recommend his work
Hapten Sciences is a venture-backed, start-up company developing novel new chemical entity where are no similar products in development or on the market. Clementi Ltd. works with Hapten on regulatory affairs issues and clinical development plans. Not only does Hapten rely on Clementi and Associates for these critical areas, but also on broad strategic and cross-functional development issues and opportunities. After having worked together for four years, Clementi and Associates Ltd is regarded by Hapten and the company partners as the most trusted and relied upon advisory group we have had.
I have used Clementi and Associates Ltd for over 5 years, across three companies, as a medical consultant. Their consulting knowledge related to safety, clinical pharmacology and INDs is always consistent with the FDA’s current thinking. Their professionalism and expeditious delivery are far above any consulting firm that I have used. They also have flexible hours and will assist you regardless of how busy they may be with other clients. Their advice and alternatives to problem-solving have been most accurate.
I have worked with Nancy and Bill Clementi at Clementi and Associates Ltd for a number of years. Focal Point Pharmaceuticals is a new company that licensed the technology for the development of ocular diseases. As a new company, we had questions about the regulatory process. We had questions about the drug candidates will be considered orphan drugs and qualify for pediatric programs with FDA. Clementi Ltd. quickly wrote strategic pathways. The result was a thoughtful decision by management to move forward as a company.
We needed support from a group who have had extensive experience working with CBER on a novel and complex BLA program. Strategically, Clementi & Associates input was invaluable to us in identifying key concession to push for. Tactically, we simply couldn’t have managed all of the submission hurdles without them.
It has been great working with Clementi Ltd. Without them, we couldn’t have moved forward a number of important clinical trials at the FDA. They are knowledgeable, efficient, and thoroughly professional. Highest recommendation