Global Regulatory Affairs Services

Global Regulatory Affairs team assists companies to plan and manage generic drug development programs and support in regulatory services for individual countries such as USFDA (USA), EMEA (EU), TGA (Australia), and Medsafe (New Zealand). Apart from this, airis PHARMA also provides consulting services from the early stages of generic drug product development to submission of marketing applications, post approval changes, renewals and submission of annual reports.

Country Specific Regulatory Services

USA: EU: TGA / MEDSAFE: