India

AUSTRALIA

The TGA (Therapeutic Goods Administration) operates within the Australian Government Department of Health, overseeing the regulation of therapeutic goods' import, supply, manufacturing, export, and advertising.

For your TGA registrations, rely on our expertise. Our dedicated team of TGA registration consultants offers guidance on data requirements, conducts thorough gap analyses of existing data, manages data generation, and compiles all necessary information in the required format to meet regulatory, quality & compliance standards.

Services We Offer

  • Regulatory intelligence & Regulatory strategy
  • Expert reports in line with current regulations
  • DMF review
  • Preparation, Review, Submission & registration of dossiers
  • Gap analysis
  • Data generation
  • Query responses
  • Evaluation & submission of variations
  • Labeling & Artworks
  • Lifecycle Management
  • CTD, eCTD, publishing solutions
  • Registration pathways and license management services