Home
ABOUT US
PHASE-APPROPRIATE EXPERTISE
YOUR TEAM
HISTORY
NEWS
EVENTS
JOIN OUR TEAM
PRODUCTLIFE GROUP
SOLUTIONS
SMALL MOLECULE
BIOLOGICS
MEDICAL DEVICE
CELLULAR AND GENE THERAPY
DUE DILIGENCE
REGULATORY AFFAIRS
CHEMISTRY MANUFACTURING CONTROLS
Drug Substance Services
Analytical Services
Drug Product Services
Supply Chain Services
QUALITY ASSURANCE
PROJECT MANAGEMENT
INSIGHTS
RESOURCE LIBRARY
BLOG
ASK AN EXPERT
CMC.LIVE PODCAST
STAY INFORMED
CONTACT US
HOME
ABOUT US
PHASE-APPROPRIATE EXPERTISE
YOUR TEAM
HISTORY
NEWS
EVENTS
JOIN OUR TEAM
PRODUCTLIFE GROUP
SOLUTIONS
SMALL MOLECULE
BIOLOGICS
MEDICAL DEVICE EXPERTISE
CELLULAR AND GENE THERAPY
DUE DILIGENCE
REGULATORY AFFAIRS
CHEMISTRY MANUFACTURING CONTROLS
Drug Substance Services
Analytical Services
Drug Product Services
Supply Chain Services
QUALITY ASSURANCE
PROGRAM MANAGEMENT
INSIGHTS
RESOURCE LIBRARY
BLOG
ASK AN EXPERT
🎙️ CMC.LIVE
STAY INFORMED
CONTACT US
STAY INFORMED
BLOG
JOIN OUR TEAM
EVENTS
Resource Library
Regulatory Affairs
CMC
QA
Expedited Drug Delivery
Whitepapers
Corporate Brochure
Regulatory Affairs
Regulatory Agency Representation
Regulatory Strategy Development
Management and Preparation of Regulatory Submissions
Responses To Regulatory Challenges
Breakthrough Therapy Designation Requests
Cellular And Gene Product Programs
CMC
Materials Characterization and Formulation Development
Process Development, Optimization, and Validation
Analytical Method Development, Optimization, and Validation
Stability Program Design and Management
Vendor and Contractor Identification and Management
Supply Chain Assessment And Management
CMC Regulatory Affairs Support
QA
Quality Assurance Services
Design, Implementation, and Remediation of Quality Systems
Vendor Qualification, Inspections and Mock Pre-approval Audits
Management of Compliance Situations
Expedited Drug Delivery
Process and Formulation Development Considerations
Manufacturing Scale and Launch Site Considerations
Process Validation Considerations
Analytical Development Considerations
Control Strategy Considerations
Stability Data Considerations
Quality System Alignment with BT Product Development Considerations
Download our Expedited Drug Development eBOOK
Whitepapers
What It Means to Be “Breakthrough”
Pharmaceutical Stability
How ICH Is Changing Drug Development
Know Your Process Limits
Practical SOP; Lower Cost of Goods
Timing Method Validation
Top Five Reasons for CMC Clinical Holds
Translating QbD Guidance into Development Objectives
Managing Phase 2 CMC Risk
Virtual Quality Assurance: Sponsor Responsibilities
Corporate Brochure
Corporate Brochure
Contact Us for a Capabilities Call
WHAT CAN DSI DO FOR YOU?
