Elevating Probability of Success in Regulated Industries
Comprehensive strategy & solutions tailored for Pharmaceutical, Biotech, Gene/Cell Therapy, Medical Device, and Consumer Care.
Discover Our ServicesxCMC: Comprehensive Strategy & Solutions
xCMC delivers end-to-end executive, operational, audit, qualification, validation, and remediation services tailored for the Pharmaceutical, Biotech, Gene/Cell Therapy, Medical Device, and Consumer Care industries.
From early-stage development to routine quality audits and full lifecycle support, our seasoned experts are equipped to navigate your most complex challenges. Whether you need process validation, regulatory strategy, or urgent FDA remediation (including Form 483, warning letters, or consent decrees), we provide the decisive action required.
Accelerating Approval, Mitigating Risk
By leveraging our integrated suite of services, we optimize your drug product candidate's trajectory, potentially boosting your FDA approval probability from the standard 14% to nearly 50%.
Strategic Intelligence for Investors
For Venture Capital and Investment Firms, xCMC offers proprietary analytic services designed to de-risk high-stakes decisions.
We help safeguard hundreds of millions in capital by identifying unviable opportunities early, while maximizing the success rate of your core portfolio investments.
Core Competencies
We bridge science, quality, and business to accelerate product development.
Development & Submission
- Pre-IND Strategy & Preparation
- Small Molecules & Biologics
- Combination Products
- Drug Development Pathway
CMC & Quality Control
- CMC Strategy formulation
- Chromatographic Method Development
- Analytical Method Validation
- Stability Testing & cGMP Requirements
Regulatory & Remediation
- Routine Quality Audits
- 483 & Warning Letter Remediation
- Consent Decree Support
- Primary Container Closure Qualification
Leadership
Marjan Firoozmand
Senior Pharmaceutical & Biopharmaceutical Executive
With over 30 years of industry experience, Marjan Firoozmand has cultivated a deep expertise in drug development, CMC strategy, and quality-driven commercialization. This track record spans global leadership roles across pharmaceutical, biotech, and contract development and manufacturing organizations (CDMOs).
Previously serving as Vice President, Global Segment Leader for Pharma at Nelson Labs, and Senior Vice President at Nitto Avecia Pharma Services, Marjan is highly recognized for the ability to seamlessly integrate strategic science, quality control, and robust regulatory compliance throughout the product lifecycle.
Ready to Elevate Your Project?
Let’s discuss your current challenges and accelerate your path to market approval.
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