Microbial and mammalian cell line development

Drug substance and drug product process development

Analytical and assay method development and validation

Product life-cycle management

Process Validation

Validation master plans

Viral safety plans

Tech transfer and scale-up

Pre- and post-approval comparability protocols

Setting phase-appropriate specifications and acceptance criteria

Formulation development

Stability studies

CMC regulatory strategy

Cost and process modeling, including new technologies, development path, and outsourcing

Technology Assessments

Product Assessments

Market Assessments

Corporate Quality Policies

Quality Assurance Support

Quality Systems Evaluation and Audits

Quality Agreement

Training

Quality System Design

CMC Submissions

CMC Regulatory Issues

Clinical Manufacturing

Technical Services

Validation

Commissioning

Commercial Manufacturing

Strategy

Operations

Operational Excellence

Business Process Improvement