| BA/BE |
|
|
|
|
| |
|
|
|
|
| Regulatory Inspections |
|
USFDA (EIR available on request)
WHO
http://healthtech.who
.int/pq/WHOPIR/WH
OPIR_AcuNova22-2
3Jan2008.pdf |
|
Mangalore & Manipal |
| |
|
|
|
|
Laboratory Quality
System compliance |
|
College of American Pathologists (CAP) & ISO 15189:2007 |
|
Manipal |
| |
|
|
|
|
| Lachman Consultant Services, Inc |
|
GCP, GLP, 21 CFR Part 11 and USFDA requirements |
|
Mangalore & Manipal |
| |
|
|
|
|
| Country Consultancy Ltd |
|
FDA, EMEA requirements for BA/BE studies |
|
Mangalore & Manipal |
| |
|
|
|
|
| Central Laboratory |
|
|
| |
|
|
|
|
| Laboratory Quality System compliance |
|
College of American Pathologists (CAP) & ISO 15189:2007 |
|
Bangalore |
| |
|
|
|
|
| Lachman Consultant Services, Inc |
|
21 CFR Part 11 requirements |
|
Bangalore |
