Appletree is the DRA services specialist who understands the issues and needs of the manager of European small and mid-size pharmaceutical companies.

• You are looking for support when defining your global marketing application strategy.
• You do not have the resources to compile a complete Marketing Authorization Application.

• Development of your regulatory strategy on a global scale.
• Compilation of your Marketing Authorization Application dossiers for Switzerland, the European Union / EEA Centralised or Decentralised Procedures.
• Transcription of your current Marketing Authorization Application dossier to Common Technical Document format.
• Interfacing with regulatory authorities in Europe on your behalf.
• Assisting you in meeting the regulatory requirements in connection with clinical research.

• Marketing Authorization Application EU/EEA
• Drug regulatory strategy
• Drug regulatory intelligence
• Regulatory affairs in connection with clinical research