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New Drug Applications

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NEW DRUG APPLICATIONS

In order to market a new drug product in the US, a company must prepare and submit a New Drug Application (NDA). The NDA contains critical information on the drug’s safety and effectiveness generated from clinical trial results.

TSG can provide services for the pharmaceutical and biotechnology industries and assist companies with developing a strategy, and the preparation and submission of a NDA.

  • Drug Producing Establishment Registration. TSG has experience with obtaining a drug producing establishment registrations with the FDA.
  • Strategy Development. TSG can play an active role in developing a strategy for a NDA, ANDA or IND submissions.
  • Label Development. TSG can assist companies with developing drug product labeling based from the clinical trial results to achieve the best marketing label.
  • Scientific Expertise. TSG has Ph.D toxicologists that have experience with risk assessments and developing safety profiles of drug products or excipients.
  • Preparation of the NDA. TSG can prepare and submit all required documentation for a complete the NDA, ANDA or IND submission. TSG will also follow up with the FDA during the review process to obtain status updates.
  • US Agent. Having a US Agent is a requirement for foreign companies who wish to import their pharmaceutical, biotechnology products into the US. TSG can act as your agent and ensure that you are compliant with US regulations.

TSG is qualified to assist pharmaceutical and biotechnology companies in achieving their marketing goals. Located in Washington D.C, we are in close proximity to the FDA so we can better protect our clients’ interests.

We are prepared to assist your company in obtaining and maintaining compliance to the FDA requirements so you can sell your product. If you have any questions related to your product, or want to discuss how TSG can assist you, please contact Heather Bjornson at (202) 828-8945 or Gary Burin at (202) 828-8980.