 | Individual external GxP and/or client specification audit evaluations in
various regions such as:
 |
Asia (including China) |
|
Europe |
|
US (including Puerto Rico) |
|
| Internal audits and gap analyses
|
vs. regulatory standards and/or unique client procedures |
|
| Complete audit program tracking and management services |
| Competing regulation analysis and integration (e.g. ISO17025 with US
GMP/21CFR211; ISO13485 with US QSR/21CFR820; etc.) |
|
Supplier Quality Agreements |
| Sponsor vs. Contractor expectation/deliverable
analysis |
|
Compliance Enhancement Programs for drugs, biologics, devices, and combination products |
| CAPA system development
|
CAPA tracking program
management |
|
|
Corporate Compliance Master Plans |
