CONSULTING
Process and Formulation Development: Process Optimization; Pre-formulation and Formulation Studies;
Development and Characterization Studies; Technology Transfer
Analytical Development: Method Development; Method Transfer and Qualification; Product and Reference
Standard Characterization
Client/Sponsor Facilities: Start-up; Conceptual Design Review
Contract Facilities: RFP Preparation; Due Diligence; CMO and CTO Selection; Contract Negotiations;
Quality Agreements; Audits and Monitoring
Quality Systems: Design and Implementation; Monitoring and Assessment; Audits; Controlled Documents
Manufacturing: Strategy Development; Technology Transfer; Master Production Batch Record
Development; Process Analysis and Evaluation
Quality Control: Method Transfer and Qualification/ Validation; In-process, Lot release, and Stability
Testing; Sample Management; Stability Program Development and Management; Specifications; Comparability
Quality Assurance: Batch Production and Control Records Review; Lot Disposition; Investigations;
Change Control; Preparation for Regulatory Inspections
Project Management: Contract Site Management; Technology Transfer
Regulatory Filings: Strategy Development; Preparation of IND, IND Amendments, NDA, BLA, DMF;
Pre-NDA Meetings
Clinical: GCP Support
Validation: Facilities; Equipment; Cleaning; Analytical Methods; Process; Computerized Systems
REGULATORY EXPERTISE
U.S. FDA
International Conference of Harmonization (ICH)
European Union (EU)
World Health Organizations (WHO)
Health Canada
Japan Health Organization (MHLW)
PUBLICATIONS
The following Guides, Checklist, and Templates are available to purchase:
- Quality Agreement (QA08-1)
- Quality Management Review (QMR08-2)
- Roles and Responsibilities of the Quality Units (RRQU08-1)
- Audits (A08-1 to A08-5)
- Validation Protocols (VP08-1)
- Validation Reports (VR08-1)
- Investigations (IR08-1)
- Out Of Specifications (OOS) (OOS08-1)
Click here to download Publications and Manuals order form
