Pharmaceutical Human Factors Engineering
Helping pharmaceutical teams design, test, and validate safe, intuitive, and compliant products for real world use.
PHARMACEUTICAL HUMAN FACTORS ENGINEERING
Human factors strategy, usability testing, and validation to support safe and effective drug delivery systems and regulatory submissions.
DRUG DELIVERY & COMBINATION PRODUCTS
End-to-end human factors engineering for pharmaceutical and combination products, from early-stage research through summative validation.
PHARMACEUTICAL SOFTWARE & DIGITAL HEALTH
Usability and risk-focused design for pharmaceutical software, digital interfaces, patient support tools, and connected drug-delivery systems.
ISO 13485 certified
10+ years experience
Global regulatory expertise
(EU MDR, FDA)
Pharmaceutical products, combination products & digital health
OUR SERVICES
Pharmaceutical Product Design
Training Materials Development
PIL/IFU/User Manual Design
Packaging Design
Labelling
Website Design
Compliance Support
Human Factors Compliance Assessment
Usability Engineering File Creation
Submission support
IEC 62366-1 / FDA / NMPA
Early-stage research to confirm design inputs and ensure pharmaceutical products align with real-world user needs and behaviours.
User Research
User Needs Verification
Current Use Research
Device Research
Ethnography
User Interface Specification
User Requirements
Use-focused data generation and analysis to anticipate real-world product use and support accurate use-related risk assessments.
User Prediction
Behavior Analysis
Use-related Risk Analysis
Use Specifications
Hierarchical Task Analysis
Human Performance Evaluation
Known Use Problem Analysis (KUPA)
Design and validation of pharmaceutical user information to support safe, effective use and regulatory compliance.
User Documents
Human Factors Plans
Usability Risk Assessments (uFMEA)
Product Gap Analyses
Threshold analysis
Comparative Use, Formative and Summative Human Factors Testing to demonstrate pharmaceutical products can be used safely and effectively.
User Testing
Formative Usability Studies
Human Factors Validation testing
Summative Usability Studies
Readability Studies
Bridging Studies
Heuristic Analyses
Comparative Use Human Factors Studies
OUR VALUED CUSTOMERS
