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) |