Dynakin’s Drug Modeling & Consulting services operational philosophy is based on leveraging both in-house and international partners with who Dynakin has signed agreements. This function offers high flexibility while reducing overheads offering you optimal quality added value for your outsource project costs.

Thus, our DMC group is composed of in-house and partner consultants with over 20 years of accumulated experience in pre-clinical and clinical development who can respond with work adapted to your needs in all therapeutic areas. Our team also has extensive regulatory agency expertise as well as in protocol and report preparation.

DMC working philosophy uses the Model Based Drug Development (MBDD) and translational medicine paradigms as promoted by the FDA. MBDD in translational drug development applies to all stages of drug development. DMC also has strong public domain data (meta data) analysis expertise and librarian partners for meta database compilation. Both MBDD and metadata efforts are integrated to assist in go/no-go decisions for your agent. Further, we can add more value to your development by assisting you not only through MBDD + metadata but also by providing reporting and regulatory support.

DMC MBDD services cover the complete spectrum from Non-Compartmental (NCA), to Compartmental analysis, PK/PD analysis, population PK/PD analysis and Trial simulation. Data handled can come from our bioanalysis laboratory, from the client, from public domain metadata or from all those.

All design analysis and reporting is based on ICH guidelines, following your needs and Dynakin SOPs. Security of data is assured by a range of measures, including limited data access to personnel, regular data saves and regular data print-outs.