The Role of a US Agent
What is an Agent, from a Pharmaceutical sense? For the US, an Agent is simply someone designated to interact with the FDA on your behalf. This may seem like a simple definition, but it encompasses a great deal.
One of the first things to consider with a US Agent is their experience. Have they interacted with the FDA before? Is this a person who has handled and managed FDA interactions before? Their previous interactions are important for considering what you want this person to do.
That is another major consideration. What would you like your US Agent to do? Are they simply a pass through point, where you send them documents, and then they process them for you, or are you looking for more in depth work where they will help you in your interactions with the Agency? Both are viable options, and both have benefits for companies. If you are based outside of the US, do you want your Agent to also guide you in your interactions or do you have that expertise internally.
Your US Agent effectively becomes part of your team, and you need to choose an Agent that fits what you are looking for. In general, look for a senior consultant with at least 10+ years of experience, who has many different type of interactions with the FDA, from one-on-one interactions to FDA Meetings, both company specific and public. These will help get you an Agent which is both well rounded and also will have some reputation with the Agency.
Lessem Regulatory Consulting Group, LLC is more than happy to offer Agent Services of both kinds. Feel free to visit our website for more information: http://lrcg.consulting