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