Drug Modeling & Consulting
Dynakin’s Drug Modeling & Consulting (DMC) group provides strategic modeling & simulation based support to the pharmaceutical industry for decision making or regulatory applications. DMC employs in-house consultants based in Europe and the USA. Dynakin has a track record tested vision of FDA/EMA model based drug development (MBDD) support for state of the art method application across the spectrum of drug development from animal to MAA.
DMC has over 20 years of accumulated expertise in high added value consultation services to all therapeutic areas, at any stage or all stages of development and for start up to fortune 500 companies. DMC has world class expertise with more than 60 client companies world-wide and over 140 different projects: First Time In Man (FTIM); Phase I, II, III and post marketing trials analysis and design using CTS; Bioequivalence trials; Special Patient Populations. DMC has strong very specific expertise in PIP design and application using ontogenic MBDD. Return customer projects account for nearly 85% of all projects.
Dynakin offers a unique all-inclusive in-house GLP biolab to MBDD to regulatory & MAA support. It is an enterprise with tightly wound teams working round the clock for highest standard development optimization. DMC operations are founded on the prinicples of pro-activity, integrity, application of industry standard and state of the art methods and full traceability as well and added value accountability. Constant Internal training assures the maintenance of flexible and highly efficient teams organized around therapeutic areas or specific regulatory methods leading to extremely fast outcome turn-around rates.
Working philosophy
Services covered by DMC
Seeking consultation for drug development