Services

• Development of Drugs: from choice of the active ingredient, dosage form and drug formula up to registration
• Regulatory strategy
• Contact with Competent Authorities
• Scientific Advice with Competent Authorities
• MAAs, variations, renewals
• Updating dossiers incl. summaries and overviews
• Production and update of SmPCs, PILs and Labeling
• Assessment of dossiers in the course of license contracting
• Quality Management