Performance

Performance

Triskel can help you to bring out the best in your product in the most time-efficient way

Our technical achievements range from the design and implementation of numerous successful drug development plans, the definition and execution of optimal regulatory strategies to achieve marketing authorisation, to the delineation of healthcare policy and drafting guidelines with regulatory agencies.
In drug development, Triskel's integrated team optimises the potential of a product, while monitoring evolving regulatory requirements in order to reduce development time and ensure optimal presentation of the product submission file to regulatory authorities.

Overall development

In 24 years, Triskel has prepared 16 full development plans for its clients.
Example of efficiency of a development plan:
This cornerstone document allowed efficient planning and rigorous execution resulting in the development of a medicinal product in 23 months from start of toxicology to MAA submission (in particular, only seven weeks elapsed between the last patient visit of the 12 month Phase III study and the MAA submission). This product is now available in most worldwide markets with annual sales of more than 50M US$.

Chemical, Pharmaceutical & Biologicals /CMC

Since 1995, Triskel has prepared/conducted:
  • 39 due diligences: (CMC, non-clinical and clinical): as a result, two companies were bought, one of them for over 2bn €
  • 12 reviews of production plants, 7 audits of manufacturing facilities and 20 gap analysis resulting in significant improvements in the manufacturing process
  • CMC/Quality strategic development plans for 40 medicinal products
  • CTD preparation/review of Modules 2.3 and 3 for 33 medicinal products

Non-Clinical

Our track record for non-clinical dossiers includes:
  • Non-clinical development plans, including the review and analysis of toxicology and pharmacology results for 50 medicinal products
  • Preparation of CTD Modules 2.4, 2.6 and review of Module 4 for 24 medicinal products

Clinical

In 24 years, Triskel has prepared:
  • Strategic clinical reviews, including protocol design and writing, clinical data analyses and preparation of ICH clinical study reports for 74 medicinal products
  • Preparation of various Clinical Trial Applications (CTAs) for 13 medicinal products
  • Preparation of CTD Modules 2.5, 2.7 and review of Module 5 for 33 medicinal products

Regulatory

Over the years, Triskel has assisted clients with the approval of:
  • 34 Marketing Authorisations
  • 27 EU Paediatric Investigation Plans (PIPs)
  • 12 Orphan Medicinal Product / Orphan Drug Status Designations
  • 10 Small and Medium Enterprise (SME) status applications
Furthermore, Triskel has represented its clients in over 123 Scientific Advice meetings (EMA and EU National) /Protocol Assistance/FDA meetings, organised to optimise product development strategies.

Award