Highlights
Brief Introduction
Efficient Pharma Management Corp. (EffPha) was founded to provide high quality of clinical study design, execution and management, regulatory consultation, and IND/NDA preparation and submission for biotech and pharmaceutical companies worldwide. We focus on strategic planning and efficient management to accelerate your drug development to regulatory approval.
With multidiscipline expertise and multi-cultural familiarity, EffPha serves as your regional hub in Asia by bridging the gaps between Asian and global pharmaceutical industries to broaden your market reach.
2014-2018
| Disease Area/ Indication |
phase I-III |
Remarks |
| Headache |
UK/ Phase II |
IND application/ Clinical study management |
| Radiodermatitis |
Healthy volunteers |
IND application/ Clinical operation |
| Advanced cancer |
US, Taiwan/ Phase I |
IND application/ Clinical operation |
| Radiodermatitis |
US, Taiwan/ Phase II |
IND application/ Clinical operation |
| Peripheral T-cell lymphoma |
Taiwan/Phase III |
IND application |
| Cancer |
US, Taiwan/Phase II |
IND application/ Clinical operation |
| Sepsis |
Taiwan/Phase III |
CDE consultation/IND application/ Clinical operation |
| Cancer |
US, Taiwan /Phase I |
US FDA pre-IND meeting IND application/ Clinical operation |
| Chronic heart failure |
US |
US FDA pre-IND meeting |
| Diabetes mellitus |
US, Taiwan /Phase II |
US FDA pre-IND meeting/ IND application /Clinical operation |
| Selenium deficiency |
Taiwan |
BSE submission/ NDA application |
| Rheumatoid Arthritis |
Taiwan |
CDE consultation |
| Cancer |
Taiwan/ Phase I |
CDE consultation |
| Health food permit registration |
Taiwan |
Health food permit registration |
| Rheumatoid Arthritis |
Taiwan |
NDA package preparation |
Services
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Clinical Trial Service: Medical documents writing、IRB submission、Phase I, Phase II, Phase III, Phase IV monitoring、Statistical analysis
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Regulatory Service: 1.US FDA: Pre-IND meeting, IND and NDA application and IND maintenance through eCTD submission 2.TW FDA: CDE consultation, IND and NDA application
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Drug Product Evaluation: Drug development consultation、Gap-analysis for regulatory submission, 、Pre (non)-clinical study management
