As everyone knows, we start with a Non-disclosure agreement and we prefer that those agreements are 2 way, however. We can use our standard agreement or a specific agreement to your company.
We have filed many INDs from paper to eCTD. We enjoy solving early development issues and managing risk while maintaining patient safety and optimal data acquisition
We do not enjoy the ANDA process. We feel that this has become more of a legal landscape rather than a science driven process.
Yes we do. We have a hosted MS Exchange server off-site and on-site. We typically use the off site server and will provide you with those addresses once our collaboration begin.
We prefer that for confidential information that you “post” your documents to our servers or a hosted server certified by us. In this way, we can control their distribution. Once we download them, they only reside on our computers.
Email is the best way to contact us as we are mobile and in constant contact with our office. We will provide those instructions to you.
Yes, we do. And we like to work with start-up companies. But we like to work in a fairly structured way when necessary so that we know that we are adding value to your company and or product.
Yes, we do and we like it. Our experience has been extensive with our friends in Europe and Asia.
Yes, we do. We can and have provided the following: -Risk Assessment and Regulatory Success Probability -Due Diligence for Product or Company Acquisition
“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…
“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 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.