Modules | Contents |
1 | Prescribing information and all the administrative information. |
2 | Clinical and non-clinical overview, pharmacology, pharmacokinetics, toxicology, overall quality summaries. |
3 | Complete pharmaceutical and technical aspects, pharmaceutical development report, Stability studies of the product, Packing and storage conditions |
4 | Complete pharmacological and toxicological study reports as non-clinical report |
5 | Clinical study Reports |