From Pre-IND to Lifecycle Management
CMC & Regulatory Consulting
Strategic, execution-focused CMC consulting across the full product lifecycle—from early development through commercialization.
Discover Our ServicesOverview
Strategic, execution-focused CMC consulting across the full product lifecycle—from early development through commercialization. 30+ years across CRO/CDMO and pharma delivering compliant, inspection-ready programs.
Core Competencies
We bridge science, quality, and business to accelerate product development.
Core Capabilities
- IND → NDA/BLA/ANDA strategy & authoring
- Analytical development, validation, stability (design & data evaluation)
- Extractables & Leachables (E&L) studies
- Primary container closure qualification
- Investigations & root cause analysis
Industries Served
- Pharma | Biopharma
- Oligonucleotides & Peptides
- Combination Products & Devices
Quality & Compliance
- GMP-compliant QMS design
- Audit readiness & inspection support (FDA, EMA)
- Data integrity (ALCOA+), CAPA, risk systems
Digital & Innovation
- 21 CFR Part 11 & CSV
- AI-enabled labs & QMS
- Predictive quality & automated CAPA
Differentiators
- 30+ years of leadership in CMC
- Clinical to commercial expertise
- Strong regulatory track record
- Integration of science, compliance, and digital innovation
Ready to Elevate Your Project?
Let’s discuss your current challenges and accelerate your path to market approval.
Tel: 949-339-7439 and 949-874-6452