CMC CONSULTING SERVICES
CMC Consulting
Hands-on expertise for biotechs who want real answers.
About Bio Pharma Gal
Comprehensive Program Assessment
For investors, acquirers, and biotech leadership evaluating drug programs.
Pre-IND through Phase 2 program assessment
Drug substance and drug product evaluation
CDMO/supplier risk assessment
Manufacturing readiness scoring
Heat map visualization of CMC risks
Deliverable: Comprehensive due diligence report with risk ratings
REGULATORY STRATEGY & COMPLIANCE
Navigate Complex Requirements
Navigate complex regulatory requirements across global markets.
Pre-IND through Phase 2 program assessment
Drug substance and drug product evaluation
CDMO/supplier risk assessment
Manufacturing readiness scoring
Heat map visualization of CMC risks
Deliverable: Comprehensive due diligence report with risk ratings
CLINICAL SUPPLY CHAIN
End-to-End Supply Strategy
End-to-end clinical supply strategy and execution support.
Clinical supply forecasting and demand planning
IRT/RTSM system selection and implementation
Depot network strategy
Comparator sourcing
Cold chain and biologics logistics
Investigational product labeling and packaging
CDMO SELECTION & MANAGEMENT
Find the Right Partners
Find and manage the right manufacturing partners.
CDMO landscape analysis and shortlisting
RFP development and bid evaluation
Tech transfer oversight
Relationship management advisory
Quality agreement review
PROGRAM RESCUE & TROUBLESHOOTING
When Things Go Sideways
Expert intervention when you need it most.
Manufacturing issue diagnosis
Supply chain crisis management
Regulatory response support
Program acceleration strategies
Ready to get started?
Let’s transform your vision into actionable strategy. Begin your journey with us today.
Engagement Models
Flexible approaches tailored to your needs
Project-Based
Defined scope, fixed deliverables
Retainer
Ongoing advisory support
Workshop/Training
Team capability building
Who This Is For
Pre-clinical and clinical-stage biotechs
Building your CMC foundation and preparing for regulatory submissions
Venture capital and private equity firms
Conducting due diligence on potential investments
Biotech leadership teams
Preparing for milestones and scaling operations
Companies navigating transitions
Managing CDMO changes or manufacturing challenges
Let’s Talk
Every engagement starts with a conversation to understand your specific situation.