Services to Ease FDA Regulatory Compliance

All You Need To Know Responsibilities Of An FDA US Agent

30

Apr

2019

In the United States, FDA US Agent plays an important role in regulatory compliance activities. Further, regulatory compliance has a direct impact on your business. It remains U.S Agent responsibility to assist FDA to communicate 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 communicate any compliance action or FDA communication promptly with foreign companies.

Below are the responsibilities of U.S Agent.

  1. Assist the FDA to communicate with foreign companies  
  2. Assist the FDA to organize inspection
  3. U.S Agent plays an important role while filing IND, ANDA or  NDA
  4. If required, handling controlled the correspondence
  5. Signing the required forms for drug approval applications

How to choose the right U.S Agent

Confidentially  

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, it is important that U.S Agent or their affiliated companies are not engaged in a similar business to your company. Before choosing any service provider you must understand that they are not involved in similar business promotion or trading. FDA basics are dedicatedly offering regulatory consulting services.

Understanding or regulatory requirements

Your U.S Agent should understand regulatory requirements so that they can effectively communicate with the FDA and also assist you to understand any regulatory compliance related message received from the FDA.

Prompt Action

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 10 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

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 purpose. 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.

Conclusion :

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.

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