Dynakin offers Services and Products for the pharmaceutical industry and clinical care with a philosophy based on translational medicine and treatment individualization.
With its Services as a biopharmaceutical CRO (Contract Research Organization) Dynakin addresses drug development issues across two dimensions, GLP Bioanalysis and Model (and simulation) Based Drug Development (MBDD) decision making with our DMC group. The company has extensive knowledge in performing and in accompanying partners and clients through the R&D for drug development from pre-clinical, FTIM, and Phase I up to Phase III and IV clinical trials. Among the services already offered our clients are GLP services for Oncology, Allergies and Immunosuppression then also MBDD and metadata based consulting using Modeling & Simulation for strategic decision making in Alzheimer’s, Rheumatoid Arthritis, Allergies, Oncology, Immunosuppression, Inflammatory Bowel Disease, Chronic Obstructive Pulmonary Disease.
Dynakin’s DMC group has a strong presence in the regulatory aspects of drug development and bioequivalence with an important roster of repeat clients. Cases were successfully resolved both in the development and licensing of novel agents and in the bioequivalence approval domain. Dynakin’s senior level regulatory experts successfully accompanied products to the EMA and other European Member State agencies (BfarM).
The company's 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® Dynakin’s frontline 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.
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