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| The Company has implemented or is in the process of implementation of Quality Management Systems as per
ISO 9001 & 13485 for : |
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| Industries Manufacturing Products like: |
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Sterile Single use Medical Devices, Infusion sets, Catheters & Tubes, Syringes, Intra Ocular Lenses, IUD, Sutures, Coronary Stents, Drug Eluting Stents, Electro Medical Devices, Orthopedic Implants etc.
The company has undertaken projects for medical device regulations in China, Southeast Asia, UAE, Europe etc. |
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| The Company has implemented or is in the process of implementation of CE certification as per
MDD/93/42 for: |
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| Sterile Single use Medical Devices, Infusion sets, Catheters & Tubes, Syringes, Intra Ocular Lenses, IUD, Sutures, Electro Medical Devices, Orthopedic Implants, Coronary Stents, Drug Eluting Stents etc.(Devices in class I (Sterile), IIa, IIb and class III). |
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The Company has implemented or is in the process of implementation of US-FDA registration as per
pre-market notification (510k) for: |
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| Sterile Single use Medical Devices, Infusion sets, Catheters & Tubes, Syringes, Respiratory Masks etc. (Devices in class I and II ). |
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| Unikal Consultants has undertaken Active Pharmaceutical Ingredients (API) Projects : |
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| These include process setup at laboratory scale and up-gradation to Plant scale, Production, establishing QA systems and analytical methods etc.
We have successfully completed projects for plant setup / process setup at Ahmedabad, Bangluru, Mumbai, Hyderabad, Chandigarh, Delhi, Gurgaon, Kolkatta & other cities in India. DMF prepared as per US-FDA requirements for 5 Active Pharmaceuticals Ingredients and 6 more DMF are under preparations.
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