Final dosage form development

♦ Final dosage form development and manufacturing:

–	Development of final dosage form technologies and product introduction to manufacturing
–	Validation of manufacturing process and analysis methods
–	Development of drug registration documents in CTD, eCTD in compliance with the EU requirements as well as development of drug registration documents in compliance with the requirements of CIS.

♦ Consider patent renewal potential for original products with the expiring patent term

♦ Qualitative brand-generic development for original products with the expiring patent term

FDF development

Ēriks Ivanovskis
Head of Development Department