End-to-End Development Expertise, from Product Planning to Manufacturing and Regulatory Approval
POONGLIM Pharmatech possesses comprehensive, one-stop capabilities to manage the entire product development process in-house—from product planning and project development to design engineering,
mold and prototype fabrication, quality testing, finished-product manufacturing and evaluation, technical documentation review, and regulatory approval.
Through specialized expertise at every stage and a closely integrated collaboration system, we shorten development timelines, ensure consistent quality, and serve as an end-to-end development partner that transforms customer concepts into commercially viable products ready for market launch.
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STEP01
Product Planning
- Customizing Analysis
- Product Planning
- Kick-Off Meeting
- Validation Protocol
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STEP02
Product development and design
- Product Design Drawing
- 2D & 3D Modeling
- Design Validation
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STEP03
Mold making & Prototypes
- Proto mold
- Proto mold Product
- Equipment Validation
- Installation Validation
- Performance Validation
- Operation Validation
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STEP04
Quality Inspection
- Physicochemical Tests
- Biological Tests
- Stability Tests
- Dimension Spec Tests
- Leak Tests
- Silicone Oil Tests
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STEP05
Finished Product & Production Evaluation
- Process Validation
- Product Spec Validation
- Packaging Validation
- Sterilization Validation
- Product Evaluation
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STEP06
Technical Documentation Submission & Certification
- Technical Documentation
- Technical Document Submission and Inspection
- Document Validation
- The Final Quality Assurance Statement Issuance