Clinical Pharmacology Services
Our Clinical Pharmacology Services are designed to support every phase of drug development with scientific precision. We develop and implement comprehensive clinical pharmacology strategies that optimize study design and dose selection. Our team conducts robust PK/PD modeling and simulation to generate critical insights and guide decision-making. We prepare high-quality clinical pharmacology sections for regulatory submissions, ensuring compliance and clarity. By integrating Model-Informed Drug Development (MIDD) approaches, we help you reduce uncertainty and streamline development timelines. Our experts collaborate closely with your team to align clinical plans with regulatory expectations.
Drug Development Strategies
- Strategic Gap Analyses and Analysis Planning
- First in Human Dose Selection
- Clinical study protocol
- Clinical study reports
- Investigational New Drug (IND) Application
Drug Development Process
- Non-Compartmental Analysis
- Concentration-QT Analysis
- Data Programming
- Design well thought through Clinical Trials
- Question-based Review (QbR)
Submission
- New Drug Application (NDA)
- Pediatric Investigation Plan (PIP), Pediatric Study Plan (PSP
- Orphan Drug Designation application (ODD
- Breakthrough Therapy Designations application
