Romaker & Associates

Romaker & Associates is a specialized life sciences consulting firm focused on clinical pharmacology, pharmacokinetics (PK), and pharmacodynamics (PD). The firm provides strategic and technical expertise to biotechnology and pharmaceutical companies, assisting with drug development programs from pre-clinical stages through regulatory approval. Their core services include PK/PD modeling and simulation, clinical pharmacology strategy, and the preparation of regulatory documents such as INDs, NDAs, and BLAs. Led by Dr. James Romaker, the consultancy supports a wide range of therapeutic areas by optimizing dose selection and characterizing drug disposition. The firm also provides due diligence support for investors and companies evaluating potential drug candidates. By integrating pharmacometrics into the development process, Romaker & Associates helps clients streamline their clinical trials and improve the probability of regulatory success.