Six Pillars That Anchor Your Program
Process Development and Validation
QbD-led upstream and downstream development for microbial fermentation, nucleic acid, and drug product programs. DOE-driven optimization designed for scale from the outset.
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Tox Batches
Non-GMP and GMP engineering runs to demonstrate process robustness, generate toxicology material, and de-risk the transition to clinical manufacture.
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cGMP Manufacturing and Regulatory Support
Clinical and commercial GMP manufacturing across microbial drug substance, nucleic acids, and sterile drug product. In-house GMP release testing.
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Analytical Development
ICH-aligned method development, validation, and lifecycle management. Release testing, comparability packages, stability studies, and full analytical packages for regulatory submissions.
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Cell Line Development
Sequence optimization, expression vector selection, strain screening, and cGMP cell banking. Programs begin with research cell bank generation and progress through to fully characterized master and working cell banks.
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Formulation Development
End-to-end formulation support including reverse engineering for ANDA and 505(b)(2) pathways. Solubility, stability, and compatibility strategies through to cGMP-ready scale-up.
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Your Process. Our Responsibility.
Structured gap analysis, proactive risk mitigation, and dedicated project oversight from day one.
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One Program. One Point of Accountability.
A dedicated project manager with full program visibility
across Drug Substance and Drug Product.
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How We Work with You
We start by understanding your molecule, timeline, and regulatory path. Shared clarity from day one shapes everything that follows.
Alignment from Day One
Every program begins with a shared understanding of your molecule, your timeline, and your regulatory strategy. Ownership is established from the outset, and your team always knows where the program stands.
Proactive by Design
Risks are identified and communicated before they affect your timeline. We manage milestones with discipline, adjust course early, and keep your program moving without disruption.
Partnership Over Process
We treat your program as our own. Scientific decisions are made collaboratively and our commitment grows with your program at every stage.
Discuss Your Program With Us
Connect with our experts and see how disciplined execution and true partnership can accelerate your success.