ABOUT PREM
Prem aims to convert your medical device ideas and projects into final products in the market to provide global and innovative solutions for human health.
Why
WHY PREM?
From research to execution of life saving products, innovative solution-oriented thinking, scientific design and sophisticated development based on deep risk analysis and advanced engineering.
Testing
Contacts on global test service suppliers
Creative Ideas
Regular follow-up of updated innovation and international regulatory trends
Experience
More than 10 years of experience in Class III medical device development
Relationships
Close relationships with Key Opinion Leaders from different areas
Our Services
If you have a new or revision idea on a Medical Device or Medicinal products for human use and you look for a feasibility analysis, patent application, developing the final product, preparing regulatory files to get market approvals, implementing international requirements into your company’s system, pricing and reimbursement application for your medicinal product then feel free to contact with the Prem Team providing services with research based technical infrastructure.
If you have an ongoing project or an established R&D system and want to learn your gaps before your audit or before your submission, then feel free to contact with the Prem Team.
If you have questions on Vigilance system regarding how to implement it and communication with national authority, then feel free to contact with the Prem Team.
Device Development
Building project plans for new medical device development
Project Management
Project management with CE, MDR, FDA and MDSAP compliant records & preparation of Technical and Design History Files
Gap Analysis
Review of existing documentation to find out the missing requirements for CE or FDA applications
Risk Management
Risk Analysis and Reporting
Usability/ Human Factor Engineering
Training and filing of usability process
Prototyping
Design and prototype development
Tests and Analysis
Consultancy on how to perform technical tests and solutions for your existing project bottlenecks
Manufacturing Line Advisory
Establish manufacturing line for serial production
Pre-clinical Testing
Support on protocol and report preparation for preclinical tests
Grant Applications
National and international grant applications and management
Training
Training for your R&D and QA teams on Design Control Training for your R&D and QA teams on Design Control Processes
Patent Filing
Literature and Patent Search for your ideas, National and international IP applications and management
Vigilance
Evaluation of vigilance case and support on filing and communication with national authority
Pricing & Reimbursement
Determination and identification of new product price, application to national authority for reimbursement
Product Development
Manufacturing and process development, strategic early-stage drug development. CMC documentation review, technology transfer, analytical methods development and validations, stability and efficacy studies, preclinical testing, non-clinical studies (Pharmacodynamics and toxicology)
Licensing of Medicinal Products for Human Use
Preparation of CTD files for regulatory application and approval, change management on existing license
Gap Analysis
Review and control of exising filing such as, Product Information and IFU documents based on the recent requirements
Type I&II Variations Changes
Preparation of change filing
Pricing & Reimbursement
Determination and identification of new product price, application for reimbursement
Patent Filing
Literature and Patent Search for your ideas, National and International IP applications and management
Stay in touch with Us!
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