Who We Know
Clementi and Associates, Ltd. maintains relationships with many physicians, discovery and development scientists, specific CMO’s (nasal sprays, metered dose delivery for small molecules and biologics) which allows us to “extract” their unique skills to resolve complex issues related to drug development and commercialization. Resolving “show stoppers” at milestones decision points in drug life cycle is necessary for product development progress. Our network is enabled using custom web-based and team-based project management and workflows.
Our network extends to select CMO’s globally, analytical testing labs for biologics globally, toxicology laboratories with GLP legacy, country specific regulatory collaborations, and Phase I Units globally.
Every drug development program has unforeseen issues which require independent evaluation and thoughtful review. Now, the drug development landscape is constantly changing with new product successes and failures.
We have developed and cultivated our relationship with many groups here and in Europe and we value those relationships. In some cases, we will create a custom team where everyone on the team has unique product experience. We optimize the team as the project evolves. In this way, our teams become cost effective and less burdensome to manage. With the advent of web based solutions, we can now video conference, collaborate, exchange, assemble and submit documents to FDA or EMA efficiently. While face-to-face meeting remain important, we can now optimize them.