| - | Assistance with manufacturing and product transfer |
| - | Assistance with API requirements |
| - | **NEW** Assistance with formulation and process development (See Company News for more details) |
| - | GMP compliance from start of manufacturing to product release |
| - | Quality systems set-up and/or improvement |
| - | Cost reduction through quality systems |
| - | Pre-inspection preparation for government regulatory inspections and/or third party inspections |
| - | Support during regulatory inspections and/or third party inspections |
| - | Post inspection follow-up |
| - | Inspections of contract manufacturers, packagers, laboratories, suppliers and distribution centers |
| - | Internal audits |
| - | Assistance with GMP compliance requirements for contracts (what should you put in your contract prior to signing on the dotted line??) |
| - | Documentation compliance |
| - | Stability set up and data review |
| - | SOP preparation |
| - | Batch record review |
| - | Product release |
| - | Preparation of Site Reference File |
| - | Annual product reviews |
| - | Contact person between contract manufacturers, laboratories, government regulatory agencies, distribution centers and other contract services |
| - | Deviation and Out of Spec (OOS) investigation and resolution |
| - | Assistance with returned products |
| - | Assistance with recalls |
| - | Complaint resolution |
| - | Set up of on-going training programs |
| - | Training |