Overall development plan
In 16 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:
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3 complete due diligences: (CMC, non-clinical and clinical): as a result, two companies were bought, one of them for over 2bn €
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7 reviews of production plants, 6 audits of manufacturing facilities and 14 gap analyses resulting in significant improvements in the manufacturing process
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CMC/Quality strategic development plans for 33 medicinal products
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CTD preparation/review of Modules 2.3 and 3 for 21 medicinal products
Non-clinical
Our track record for non-clinical dossiers includes:
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Non-clinical development plans, including the review and analysis of toxicology and pharmacology results for 41 medicinal products
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Preparation of CTD Modules 2.4, 2.6 and review of Module 4 for 19 medicinal products
Clinical
In 16 years, Triskel has prepared:
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Strategic clinical reviews, including protocol design and writing, clinical data analyses and preparation of ICH clinical study reports for 61 medicinal products
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Preparation of various Clinical Trial Applications (CTAs) for 13 medicinal products
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Preparation of CTD Modules 2.5, 2.7 and review of Module 5 for 23 medicinal products
Regulatory
Over the years, Triskel has assisted clients with the approval of:
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27 Marketing Authorisations
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14 EU Paediatric Investigation Plans (PIPs)
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7 Orphan Medicinal Product / Orphan Drug Status Designations
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5 Small and Medium Enterprise (SME) status applications
Furthermore, Triskel has represented its clients in over 71 Scientific Advice meetings (EMA and EU National) /Protocol Assistance/FDA meetings, organised to optimise product development strategies.
