| BA/BE |
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| Regulatory Inspections |
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USFDA (EIR available on request)
WHO
http://apps.who.int /prequal/WHOPIR/WHO PIR_AcuNova22-23Jan2008.pdf
http://apps.who.int/ prequal/WHOPIR/WHO PIR_AcuNova21Jan2008 .pdf |
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Mangalore & Manipal |
| |
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Laboratory Quality
System compliance |
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College of American Pathologists (CAP) & ISO 15189:2007 |
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Manipal |
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| Lachman Consultant Services, Inc |
|
GCP, GLP, 21 CFR Part 11 and USFDA requirements |
|
Mangalore & Manipal |
| |
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| Country Consultancy Ltd |
|
FDA, EMEA requirements for BA/BE studies |
|
Mangalore & Manipal |
| |
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| Central Laboratory |
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| |
|
|
|
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| Laboratory Quality System compliance |
|
College of American Pathologists (CAP) & ISO 15189:2007 |
|
Bangalore |
| |
|
|
|
|
| Lachman Consultant Services, Inc |
|
21 CFR Part 11 requirements |
|
Bangalore |
