Strategy Development |
| » Product Development |
» Process & Test Method Development |
| » Due Diligence Evaluation |
» Risk Analysis |
| » High Potency Processing, Sterility, and Controlled Environment |
» Quality Systems - QSR, ISO 9000, ISO 13485 |
| » Compliance Auditing & Remediation |
» Training & Evaluation |
| » Technical Writing |
» Business Process Streamlining |
| » DEA and Chain of Custody Programs |
|
Development Services |
| » Formulation Development |
» Clinical Trial Materials Preparation |
| » Methods Improvement and Optimization |
» Technology Transfer |
| » Laboratory Equipment Relocation |
» Process Optimization / Improvement |
| » Process Development, Improvement and Optimization |
» GAMP and cGXP Training where X = M,L,C |
| » Test Method Validation |
» Chain of Custody Programs |
| » Statistical Experimental Design |
|
Regulatory
Services
|
Operational Review |
| » Product Development |
» Risk Analysis |
| » Sterility Validation |
» Statistical Process Control |
| » Vendor Audits |
» Cleaning Validation |
| » Equipment, Facility, & Software Assessment |
» ICH, ISO 9000 & ISO 13485 Pre-Assessment Baseline Audits |
| » High Potency Manufacturing and Chain of Custody |
» Reliability, Manufacturing, & Maintainability |
| » Design Control |
|
Issues Management |
| » Compliance Management |
» FDA 483 Responses |
| » Warning Letter Responses |
» Quality Systems Documentation Programs |
|
Engineering
Services
|
| » Facility Commissioning Programs |
» Process Control and Automation |
| » Process Development |
» Utilities Qualifications |
| » Process Design |
» Technology Transfer |
| » Process Engineering |
» Production Equipment Relocation |
| » cGMP Training |
» Semisolids Manufacture and Packaging |
| » Process Training |
» Scrap Reduction Programs |
| » Packaging Engineering |
» Hazards and Risk Management |
| » Process Optimization / Improvement |
» Clean Room Operations |
| » Engineering Studies |
» Sterile and Aseptic Production Processes |
| » Laboratory Equipment Characterizations and Qualification |
» Solid and Liquid Oral Dosage Manufacture and Packaging |
| » Statistical Experimental Design |
» Business Process Re-Engineering (BPR) |
| » Process Equipment Qualification |
» Equipment Relocation |
| » Design Control Implementation |
|
Validation
Services
|
| » Validation Master Plan Development |
» Test Method Validation |
| » Cleaning Validation - CIP/SIP |
» Facility Commissioning Programs |
| » Computer Validation |
» Process Equipment Characterizations |
| » Process Validation |
» Utilities Qualifications |
| » Equipment Qualification (IQ/OQ/PQ) |