serving the pharmaceutical & related industries

Pharmaceutical Consulting

Development

Pharmaceutical Development

INDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)

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Application

Pharmaceutical Application Processing

Filing and Managing all of the Processes for FDA Drug Applications

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Compliance

Pharmaceutical Compliance

FDA and Global Regulatory Compliance and Submission

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Manufacturing

Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification

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US Agent and Advisory

 PTS Pharmaceutical Consulting Global Services offers a US Agent pharmaceutical consulting service to foreign clients looking to enter US markets.

FDA-US-Agent-and-Advisor

What is a US Agent?

Title 21 of the Code of Federal Regulations establishes the definition of a US Agent

  • United States agent means a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent. This definition excludes mailboxes, answering machines or services, or other places where an individual acting as the foreign establishment's agent is not physically present. [21CFR 207.3(a)(11)]
  • The US Agent must reside or maintain a place of business in the US.
  • Upon request from FDA, the United States agent shall assist FDA in communications with the foreign drug establishment, respond to questions concerning the foreign drug establishment's products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign drug establishment. If the agency is unable to contact the foreign drug establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign drug establishment.
  • In addition, when applications are submitted or pending with the FDA, the FDA will communicate with the US Agent and the US Agent will then coordinate with the organization they represent.

Who is required to have a US Agent?

  • Title 21 of the Code of Federal Regulations establishes who is required to have a US Agent
  • Each foreign drug establishment required to register under 21CFR 207.4(a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information. 21CFR207.40(c)

PTS Global Services will work with your organization to prepare and submit applications to FDA using the eCTD format assisting your organization with the particular requirements with the FDA that are not present in other regions.

PTS Global Services will assist with identifying a commercial marketing partner which can be performed closer to launch providing additional time to find an optimal marketing partner and ultimately the best possible price for their product

  • Assistance with interpreting and understanding FDA regulations and guidance documents
  • Experienced communication relay and interface between the FDA and your organization
  • Assistance and guidance with Establishment Registration (and re-registrations), Drug Listing, and preparation for FDA inspections

 

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