|
Inspections & Compliance
- US FDA (Cursory prior to Phase III, Pre-ELA meeting)
- Thailand FDA (WHO – ELA equivalent)
- Outside consultants (Don Hill Associates, Biologics Consulting Group)
- Qualified persons for EU GMP Certification (IMP)
Clinical Trial Regulatory Approvals (Chemistry, Manufacturing & Controls)
| COUNTRY |
YEAR |
| USA (CBER) |
1996 / 1999 |
| Thailand (MOPH) |
1996 |
| Spain (AEM) |
1996 / 1999 |
| Canada (TPP) |
1999 |
| France |
2000 |
| UK (MCA) |
2000 |
| Germany |
2000 |
| Sweden (MPA) |
2001 |
|
