What we offer...

Marketing Application and Post-licensing issues  
  • Selection of European regulatory procedures
  • Optimising roduct labelling
  • Understanding and responding to non-clinical and clinical regulatory questions
  • Preparation for meetings with national authorities and EMA Scientific Committees such as CHMP, SAWP, PDCO, COMP and CAT
  • Negotiation support throughout the review process
  • Appeal procedures
        
Development Strategies  
  • Scientific and regulatory peer review at entry into man, end of phase II or prior to submission of a marketing application
  • Scientific Advice issues (EMA/CHMP and National)
  • Continuous support during development of a product targeted for an EU decentralized, centralized or Mutual Recognition procedure
   
Regulatory due diligence  
  • In depth risk assessments of internal or licensing-in projects