Regulatory Affairs services

Any regulatory activities in Poland and the EU for foreign companies entering the EU and EU/PL partners:

• Dossiers audits and preparation for entering the EU,
• Registrations of new products,
• Maintenance of existing Marketing Authorizations,

• Variations and contact with Regulatory Agencies,
• Regulatory strategy for complex tech transfers or sophisticated variations, and
• Regulatory support and regulatory intelligence.

Any regulatory activities for companies entering markets outside of the EU via our partner companies:

• India
• Vietnam
• China
• Middle East
• LATAM
• CIS
• APAC

From registration strategy and dossier audit to MA maintenance.