Prem Research and Development Consultancy
Consultancy and technical services firm supporting medical device and medicinal product development. Offers project planning, regulatory file preparation, design control and quality system support, prototyping and manufacturing advisory, preclinical testing support, and post-market vigilance and reimbursement assistance. Positions itself as a bridge from research to market for Class III medical devices and early-stage drug development.
Industries
Nr. of Employees
small (1-50)
Services
Project planning and management for new medical device development.
Project management with preparation of quality records and technical/design history documentation to meet international regulatory requirements.
Review of existing documentation to identify missing elements for regulatory submissions.
Risk analysis and reporting to support development and regulatory compliance.
Training and preparation of usability processes and associated documentation.
Design and prototype development for device concept validation.
Project planning and management for new medical device development.
Project management with preparation of quality records and technical/design history documentation to meet international regulatory requirements.
Review of existing documentation to identify missing elements for regulatory submissions.
Risk analysis and reporting to support development and regulatory compliance.
Training and preparation of usability processes and associated documentation.
Design and prototype development for device concept validation.
Expertise Areas
- Medical device development
- Early‑stage pharmaceutical development and CMC
- Regulatory submissions and compliance (technical files and CTD preparation)
- Design control and quality management systems
Key Technologies
- Design controls and Design History File preparation
- Regulatory submission preparation (CTD and technical files)
- Risk management and hazard analysis
- Human factors and usability engineering