Drug Development

New Opportunity Evaluation
Strategy Development
Program Planning
Regulatory Strategy
Contract Management

Regulatory

Support GLP preclinical study designs / outsourcing / management
Pre-IND / CTA submissions
IND / CTA submissions
Management of agency meetings
Orphan Drug eligibility evaluation / submission

Strategic Business Planning

Strategic Planning and Research
Technical Evaluation
Process Development Planning

Operational

Process Development Planning
Schedule Development
Process Implementation
Negotiating Contract Research Support
Project Management

Contract Manufacturing Support

Prepare Requests For Proposals
Evaluate Manufacturing Organizations
Due Diligence Inspection
Manage Technology Transfer
Manage Manufacturing Projects

Manufacturing Process Implementation

Clinical Trial Product Process Development
Commercial Scale Process Development
Specification and Characterization Planning
Process Optimization Analysis
Process Failure Analysis