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.

Trusted expertise. Proven impact.

Why leading teams choose THAY Pharma

ISO 13485 Certified

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10+ Years Experience

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Global Regulatory Expertise

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Pharmaceutical Products, Combination Products & Digital Health

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ISO 13485 Certified | 10+ Years Experience | Global Regulatory Expertise | Pharmaceutical Products, Combination Products & Digital Health |

Our Services

  • User Needs Verification

  • Current Use Research

  • Device Research

  • Ethnography

  • User Interface Specification

  • User Requirements

User Research

Use-focused data generation and analysis to anticipate real-world product use and support accurate use-related risk assessments.

  • Formative Usability Studies

  • Human Factors Validation testing

  • Summative Usability Studies

  • Readability Studies

  • Bridging Studies

  • Heuristic Analyses

  • Comparative Use Human Factors Studies

User Testing

Studies and tests to demonstrate pharmaceutical products can be used safely and effectively.

  • Human Factors Compliance Assessment

  • Usability Engineering File Creation

  • Submission support

  • IEC 62366-1 / FDA / NMPA

Pharmaceutical product design

  • Training Materials Development

  • PIL/IFU/User Manual Design

  • Packaging Design

  • Labelling

  • Website Design

Compliance Support

Early-stage research to confirm design inputs and ensure pharmaceutical products align with real-world user needs and behaviours.

  • Human Factors Plans

  • Usability Risk Assessments (uFMEA)

  • Product Gap Analyses

  • Threshold analysis

User Prediction

  • Behavior Analysis

  • Use-related Risk Analysis

  • Use Specifications

  • Hierarchical Task Analysis

  • Human Performance Evaluation

  • Known Use Problem Analysis (KUPA)

User Documentation

Design and validation of pharmaceutical user information to support safe, effective use and regulatory compliance.

OUR VALUED CUSTOMERS

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