Regulatory Intelligence

  • Regulatory positioning of your product or project
  • Specific requirements
  • Precedents and current thinking

Regulatory Strategy

  • Advice on definition of optimal product development plans according to specific regulatory requirements in different geographical areas
  • Agreement of development plans with Regulatory Agencies, Scientific Advice and FDA meetings
  • Advice on answers to regulatory bodies

Regulatory Support

  • Preparation or review of regulatory documents: IMPD, IND, CTA, DMF, PIP..
  • Scientific Advice or FDA Meeting Packages
  • Preparation or review of answers to regulatory bodies

On demand Regulatory Services