Finding creative means to help our clients achieve their goals

Triskel often works with first-in-class products that present new scientific, regulatory and legal issues and has first-hand drug development and regulatory expertise in areas as diverse as biosimilars, advanced cell and gene therapies and transgenic products.
For example, Triskel was instrumental in the development and CTD submission of the first ever human cell line-derived medicinal product approved by the EMA in 1998 and of the first biosimilar/follow-on protein approved both by the EMA and FDA in 2006.
Triskel's ground-breaking projects with innovative products for which no appropriate regulatory guidance existed has led directly to the development of regulatory and legal frameworks for several new EU guidelines.
Regardless of the nature of the molecule, Triskel provides customised, strategic services responsive to our clients' goals. Our "learning/confirming" approach to drug development is designed to offer timely, cost-effective and efficient strategies to steer a molecule from discovery to the market.

First in human cell line-derived medicinal products

In 1996, the first MAA filed by Triskel through the EU centralised procedure was for a fully human mAb produced by Epstein-Barr virus-transformed human B-lymphocyte cells. This mAb also represented the first ever human cell line-derived medicinal product to be approved in the EU.