Experts in literature reviews
If progressing with either a literature-based or hybrid TGA application, a systematic literature review is required. Systematic literature reviews are more than simply entering key words into your PubMed or Embase search. Ahead of even assessing the supportive literature, the TGA will seek to understand the search has been undertaken in such away that it is reproducible and without bias. We pride ourselves on our ‘slick’ process for undertaking systematic literature searches, identifying and applying exclusion criteria, and preparing the relevant sections of your application
We also offer what we call feasibility-based systematic literature reviews. These feasibility-based systematic literature reviews help to understand whether a systematic literature review would contain sufficient information for a TGA literature-based or hybrid submission. They are also helpful in cases where literature support is sought but the effort of a systematic literature review is not needed.
Contact Enimera RegPlus to enquire about our pricing options.
Systematic literature reviews for literature of hybrid (mixed) applications
Literature reviews are a mandatory component of TGA new substance (ingredient) applications.
Non-systematic literature review are helpful in keeping up with developments of interest. We run one-off or regular literature searches by active ingredient, by author (name or organisation), by indication, and also by other criteria as relevant to you, with reports delivered straight to your inbox.
Contact Enimera RegsPlus to enquire about our pricing options.
We are the experts in literature searches. Contact the Enimera RegsPlus team to learn about our process and pricing options.