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Module 4 & 5 (Literature based for CTD dossier)

MYdossier is a global leader in regulatory consulting and Module 4 & 5 solution for export registration. We write and review Module 4 & 5 (Literature based) as per European CTD.

MODULE 4 Non Clinical Study Reports
4.1 Table of contents
4.2 Study Reports
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
4.3 Literature References

MODULE 5 CLINICAL STUDY REPORTS
5.1 Table of Contents
5.2 Listing of All Clinical Studies
5.3 Clinical Study Reports
5.3.1 Biopharmaceutics Reports
5.3.2 Studies Pertinent to Pharmacokinetics using Human Biomaterials
5.3.3 Human Pharmacokinetics
5.3.4 Human Pharmacodynamics
5.3.5 Clinical Efficacy and Safety Studies
5.3.6 Reports of Post-Marketing Experience
5.3.7 Case Report Forms and Individual Patient Listings
5.4 Literature References

We also make clinical and toxicology studies (ACTD / non-CTD format) as per ROW countries