Track Record
Track Record
In 25 years Triskel has provided over 130 Biotech and Pharma companies with strategic consulting on the following:
Recombinant proteins
mAbs
Peptides
Vaccines (therapeutic and prevention)
Extracted biologics
Cell-based medicinal products
New Chemical Entities
Resulting in more than 35 Marketing Authorisations.
Awards
In 2013 Triskel Integrated Services SA was nominated for the TOPRA award for regulatory excellence and received the TOPRA prize.
In 2019 Triskel Integrated Services SA received a badge of honor from IFAH
Achievements
Our achievements range from the design and implementation of numerous successful drug development plans, definition and execution of optimal regulatory strategies, all the way towards obtaining a marketing authorization
Successful completion of ground-breaking projects with innovative products for which no appropriate regulatory guidance existed, delineation of healthcare policy and drafting of respective guidelines with regulatory agencies
Our track record includes:
CMC/Quality development plans for 40 medicinal products,
16 full development plans,
39 due diligence cases (CMC, non-clinical and clinical, non-clinical development plans),
review and analysis of toxicology and pharmacology results for 50 medicinal products as well as strategic clinical reviews,
protocol design and writing, clinical data analysis and preparation of ICH clinical study reports for 74 medicinal products