In the United States, FDA US Agent plays a vital role in regulatory compliance activities. Further, regulatory compliance has a direct impact on your business. It remains the U.S Agent’s responsibility to assist the FDA in communicating with foreign companies when such communication is necessary. U.S Agent should be capable of understanding FDA compliance related matters and effectively communicate with foreign companies. Also, U.S Agent should share any compliance action or FDA communication promptly with foreign companies.
Below are the responsibilities of the U.S Agent.
- Assist the FDA to communicate with foreign companies
- Assist the FDA to organize inspection
- U.S Agent plays an important role while filing IND, ANDA, or NDA
- If required, handling controlled the correspondence.
- Signing the required forms for drug approval applications
How to choose the right U.S Agent
Confidentiality is the key to the success of any business. Your U.S Agent should maintain the strict confidentiality of the information related to your business. We, at We, maintain strict confidentiality of all your information.
Conflict of Interest
Since U.S Agent is aware of your products, U.S Agent or their affiliated companies mustn’t be engaged in a similar business to your company. Before choosing your US Agent, you must understand that they are not involved in similar business promotion or trading. FDA basics are dedicatedly offering regulatory consulting services.
Understanding of regulatory requirements
Your U.S Agent should understand regulatory requirements so that they can effectively communicate with the FDA and also assist you in understanding any regulatory compliance related message received from the FDA.
U.S Agent should be capable of promptly passing the regulatory actions or information received from the FDA without any delay. Since any regulatory actions in the drug approval process may impact your application review and delay the approval process. Some of the minor comments raised during ANDA filing have ten days response, so it becomes very important for a sponsor that they should get FDA communication in real-time.
U.S Agent for Food and Dietary Supplement facilities
The appointment of U.S Agent is mandatory for foreign food facility registration. During food facility registration, foreign companies must provide U.S Agent details. Pragmatic can act U.S Agent for your food facility and assist for obtaining food facility registration without additional fees.
U.S Agent for Medical Device Companies
Medical device companies are also required to appoint U.S Agent for medical device registration and listing purposes. We offer U.S Agent services for medical device companies and assist for registration and listing.
U.S Agent services for Drug Approval or DMF
Foreign sponsors are required to identify U.S Agent for FDA communication. Controlled correspondence can be handled by U.S Agent. U.S Agent plays an important role in the drug approval process. We are offering U.S Agent services to many drug companies, so we understand the important impact of regulatory communication on your business.
The primary objective of the U.S Agent FDA to communicate with foreign companies.
U.S Agent has an important role for your business, so you must choose the U.S Agent very wisely.