We provide a wide variety of scientific, medical writing and medico-marketing material drafting services for regulatory submissions as listed below. Our inhouse experts have deep knowledge of medical writing.

  • Module 2.4 and module 2.6 (non-clinical) drafting

  • Module 2.5 and Module 2.7 (clinical) drafting

  • PSURs, PBRER, PDERS & Risk management plan

  • Drafting of product information i.e. SmPC, Leaflet, Labelling

  • Scientific justification/Biowaiver

  • Medico marketing material drafting like Doclet, visual aid, manuscript, abstract

  • Lay person summary

  • Preclinical study reports

  • Clinical study reports (Phases I to IV) and Clinical protocols

  • Investigator brochures

  • Investigational Medicinal Product Dossier (IMPD)

  • Informed Consent Forms

  • Patient Safety Narratives

  • Clinical and non-clinical Expert reports

  • Module 4 and Module 5 compilation