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.