REGULATOP

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Product Life-cycle (Rx, OTC, Medical Devices, Nutritionals, Cosmetics)

• Due diligence
• Start-up of foreign companies (including QPPV)
• Regulatory Strategy
• International Feasibility Studies
• Preparation/Revision of CTD Dossiers for submission under MRP, DCP and National procedures
• CTD reformatting and conversion into e-CTD
• Licence maintenance: Variations via Regulation 1234/2008, Renewals
• Revision of texts for Scientific Information or Advertising purposes
• OTC Switches
• Notifications for Nutritionals/Cosmetics
• Medical Devices (also Borderline): from Feasibility to registration
• Technical writing (Translations IT<->EN, Expert's Overviews, SmPC and PIL, Health Manual/SOPs)

Clinical Trials Applications

• Preparation of CTA to ECs and CAs
• Notifications of clinical trial key steps
• Administration of Osservatorio database (Italy)

Tailored Training on Regulatory aspects

• Basics of Regulatory Affairs
• Specific Regulatory subjects on Companies´ demand
• Basics of Drug Products Development