• Cost effective regulatory strategies to gain competitive advantage for new product development

For existing registered products (re-development, re-registration, etc.):

• Project management
• Compliance check/due diligence, updating and reformatting of files
• Choosing the most appropriate procedure type
• Handling all types of registration procedures for various products in the eCTD.
• Consultation on a legal basis and classification of products
• Handling registration procedures in all EU Member States.
• Preparation of Modules 1-5
• Life cycle management
• Regulatory requirements, strategies, and the knowledge of the global product dossier
• CMC documentation preparation (API and FDF)
• EDQM – obtaining CEP
• Environmental risk assessment (ERA)