EXPERTS IN DRUG DEVELOPMENT, CLINICAL PHARMACOLOGY AND PHARMACOMETRICS

Consulting Services in Regulatory and Scientific Affairs

Tailored Workshops, Courses, and Seminars

Study Designs, Sample Size Estimations, Protocols, and Analysis Plans

For innovative drug development, we can provide study designs, sample size estimations, protocols, and analysis plans for any kind of clinical pharmacology study, including:

For generic or supergeneric drug development, we can define your bioequivalence study program, including Therapeutic Equivalence studies, using a pharmacodynamic endpoint or marker if needed.

We also offer a variety of services to meet all your pharmacokinetic needs

Strategic Project Management

We provide pharmaceutical project management support, such as:

PK/PD Analysis and Reporting

Pediatric Modeling and Simulation Reports

Renal and/or Hepatic Impairment Modeling and Simulation Reports

Predictions of drug concentration-time profiles and dosing regimens for various levels of renal and/or hepatic function.

Other