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The
Company has implemented or is in the process of implementation
of Quality Management Systems as per ISO 9000 series for:
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| Industries
Manufacturing Products like: |
| Sterile
Single use Medical Devices, Infusion sets, Catheters & Tubes,
Syringes, Intra Ocular Lenses, IUD, Coronary Stents etc. Engineering
Items, Telecommunications, Electronics |
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Services
like:
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| Hospitals,
Nursing Homes, Educational Institutes, Computer Academies |
The
Company has implemented or is in the process of implementation
of CE certification as per MDD/93/42 for:
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| Products
like: |
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Sterile
Single use Medical Devices, Infusion sets, Catheters
& Tubes, Syringes, Intra Ocular Lenses, IUD, Coronary
Stents etc.(Devices in class I (Sterile), IIa, IIb and
class III).
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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| Products
like: |
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Sterile
Single use Medical Devices, Infusion sets, Catheters &
Tubes, Syringes etc. (Devices in class I, II and class III).
Unikal
Consultants has undertaken Active Pharmaceutical Ingredients
(API) and Pharma Formulation Projects. 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, Ankleshwar, Mumbai, Hyderabad, Chandigarh,
Delhi & other centers 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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