As a non-US firm seeking entry into the US pharmaceutical market, your first obstacle is finding a reliable and competent US representative. The scientific acumen and regulatory expertise of our consultants, along with a strategic location in the Washington, DC metropolitan area, make Aclairo® a logical US Agent choice for our international clients.
Our US Agent services include the following:
- Gap analysis of your regulatory submissions
- Compliance with all applicable laws and regulations
- Effective communications with the FDA
- Participation at FDA meetings and teleconferences
- Ability to submit in paper and eCTD (electronic) formats
For more information, please contact: Dana Dunn (ddunn@aclairo.com)