Welcome to HitGen


Enabling Innovative Drug Discovery with Advanced Technologies

  1. Services
  2. Regulatory Affairs

Regulatory Affairs

The Regulatory Affairs team has significant experience in drug development and establishment of regulatory strategies. This endows our clients to develop their new drugs more efficiently and to accomplish timely and successful regulatory submissions.

Key Offerings Include:

  • Dossier/submission preparation or review and filing

  • Development of regulatory strategy for the product's life cycle

  • Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process.

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