Dynakin, S.L. Information

Dynakin is the sole provider worldwide combining Model Based Drug Development with GLP Biolab, GCP clinical trial design and execution and product oriented R&D, under the same roof. During the last years, Dynakin has consolidated its presence in the main European markets, being the challenge for the following years to enter into USA market. Dynakin is a Strategic Consulting Company driving the shortest road to your drug development success, leveraging state-of-the-art Industry and regulatory standard pharmacometric methods to maximize efficiency and minimize risk and costs in development. The company has extensive knowledge in performing and in accompanying partners and clients applying PK/PD Modeling and Simulation tools through the R&D for drug development from pre-clinical, FTIM, and Phase I up to Phase III and IV clinical trials. Dynakins DMC group has a strong presence in applying Modeling&Simulation in regulatory aspects of drug development and bioequivalence. Dynakins senior level regulatory experts successfully accompanied products to the EMA and other European Member State agencies as BfarM, MHRA, and also to FDA and ANVISA. Another field of applied expertise of these Modeling and Simulation tools are special populations and trial design and execution in these, including presentation of the first pediatric investigation plan (PIP) to the EMA. Several PIPs plans have followed to different regulatory agencies. The companys high ratio of investment into R&D is geared towards integration of its Services expertise into products aiming to improve treatment individualization for adult and pediatric patients. DynaPRED Dynakins front line dose individualization routine is a web-based application soon to be fully scaled up and released as an accessory to chronic treatment drugs or as a stand alone.