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