Development of Regulatory Strategies

  • Planning of national and European registration procedures (see our list of countries)
  • Analysis and evaluation of existing documentations (dossier / ASMF)
  • Evaluation of registration chances
  • Planning and realisation of BE-studies
  • Cost analysis
  • Procurement of regulatory relevant documents (e.g. regulatory data of the original product, SPC, PIL, labelling)
  • Literature research, - procurement and - analysis © Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH