Regulatory affairs & regulatory science

Fuglsang Pharma is involved in product developments targeting the following submission bases:

  • EU: Article 8 - Innovator products
  • EU: Article 10.1/2 - Generics
  • EU: Article 10.3 - Hybrids
  • EU: Article 10a - Well-established use
  • EU: Article 10b - New fixed-dose combinations
  • EU: Article 10.4 - Biosimilars
  • US: 505(b)(1) - Regular NDAs
  • US: 505(b)(2) - Abridged NDAs
  • US: 505(j) - Generics

We are intimately familar with the European decentralised and centralised procedures as well as national submissions and mutual recognition procedures.