Services

CMC GxP Analytical Consulting Services for Biologics, Cell and Gene Therapies (CGT) and Advanced Therapies

CMC Development Strategy Consulting

Product development plan
Strategizing/advising technical development and in vitro study design
Data interpretation and storytelling in a big picture.
Phase appropriate End-to-End Control strategy.
Regulatory/Quality considerations.
Technology and Platform Evaluation
Technology Transfer to CDMO
Support CI and due diligence activities for business development

Analytical Development, Validation Consulting

Analytical Development Troubleshooting (e.g., Potency, Flow, PCR-based methods, safety test)
Recommendation of analytical methods
Data interpretation, experimental design
Reference material and assay control
Potency assay development
Method qualification/validation
Working with CDMO/CRO
Protocols, TP, SOP review
Process Analytics

Quality Control (QC) Consulting

Method qualification/validation
Tech Transfer
QC analyst training
Consideration for reference, critical reagent, assay control characterization and qualification
Advising in operating analytical labs/teams and working with CRO/CDMO

GxP Training

Cell and Gene Therapies
Technical Development
QC laboratory
SOPs and Documentation
External Partnership
Quality Audit

Regulatory Documents Support

Authoring and Reviewing regulatory filing analytical sections
Story-telling in the context of a bigger picture along with data packages from the other functions

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