We are experienced drug development scientists who have focused on medical and regulatory affairs. But we are anchored by science in every regard. We assess your product, create a plan to manage pre-approval or post approval activities, and help you implement that plan. Some refer to it as “strategy”. To us, it is good planning and consensus building. Presentation summaries are examples of our current regulatory (Sunshine Act) views, Pediatric Drug Development views, and our Submission Workflow (abbreviated.)
So we provide ADVICE and OPINION, and then incorporate those into a STRATEGY.
We are creative and we emphasis DIALOGUE and INTERCHANGE with FDA and other regulators, and when there is a FDA Meeting we work to assure the outcome is successful. To us, a successful meeting occurs when the Sponsor understands the regulator and the regulator understands the Sponsor. And there is a clear path forward.
Accordingly, we provide core services such as:
If you are evaluating line extensions or evaluating in-licensing or partnering opportunities, we can help you assess the data package and identify gaps from both a clinical and regulatory perspective, and develop a project plan especially if the plan requires a new IND as for example, when implementing the 505(b)2 pathway.
In all of these areas we can assume a variety of roles – from carrying out specific-focused assignments to organizing and managing the overall project. Through our network we can provide whatever your organization needs.
I have worked with Dr Clementi on a number of projects requiring consultation with the FDA and on each occasion his detailed knowledge of 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 seemless. He is a pleasure to work with and I would highly recommend his work.
“Hapten Sciences in 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 b…
“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 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 the strategic pathways. The result was a thoughtful decision by manageme…
“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 FDA’s current thinking. Their professionalism and expeditious delivery is 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 has been mo…