Dossiers Preparation

Our team has experience in understanding the finer aspects required to prepare quality Dossier to maintenance of marketing authorization documents with the correct combination of accuracy and efficiency, thus helping to facilitate our customers to navigate a complex biopharma environment.

Our Expertise

• Accurate, Compliant and Well integrated
• Expertise to adapt level of detail according to all development phases (phase 1-4)
• Global Patent Information and Literature for patented product
• Compilation of pharmacological/toxicological expert reports
• Marketing authorization dossiers for Medical Device & Diagnostics products
• Preparation of labeling justification document