Please connect with us for all the miscellaneous support required for submissions:
- Dossier Due diligence
- Medical writing- Co & NCO CTD Modules
- Genotoxicity study by Software
- Clinical activities :
- Clinical and non clinical Overviews and summaries modules 2.4, 2.5, 2.6 and 2.7 report writing for EU And row submission.
- Auditing and Monitoring the clinical studies from Phase –I to IV and Pilot and pivotal BE studies for sponsors or clients at the CRO.
- Genotoxicity study for API and its impurities and components by softwares
- Pharmacovigilence :
- PSURs,
- PSMF (DDPS),
- RMP,
- QPPV,
- AE’s and SAE’s reporting,
- ADR reporting.
- Readability study or User testing of PILfor EU
- Batch release/testing support for EU
- Translations
- Sourcing of RLD and reference standards
