Expertise at every step

State-of-the-art technology.  Cutting-edge science.  End-to-end services.

Expertise at every step

State-of-the-art technology.  Cutting-edge science.  End-to-end services.

Fully integrated drug development, manufacturing & testing

We are a US-based CDMO driven by the belief that scientific expertise and manufacturing excellence combined can bring innovative therapeutics to patients who need them. Our team of industry experts applies its broad experience with the sterile injectable dosage form in support of a diverse range of client projects. Our comprehensive portfolio of capabilities from lab-scale development through commercial manufacturing ensures quality, scalability and efficiency at every stage.

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Research & Development

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Research & Development

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Research & Development

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Advanced technology, collaborative approach

We have invested in state-of-the-art facilities and equipment to ensure delivery of the highest quality sterile injectable products. Our team focuses on building collaborative relationships with our clients, while leveraging our subject matter expertise to deliver a seamless experience from process development through distribution.

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Quality by Design

We systematically and proactively incorporate quality into the product from the start.
Our scientifically grounded, risk-based approach helps to ensure a robust final product that meets or exceeds global regulatory requirements and ICH standards.

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Product Development

Onsite development and testing laboratories led by highly experienced scientists.

Process development and optimization
DoE and QbD study design, execution, and statistical analysis
Technology transfer and scale-up

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Analytical Services

Advanced characterization and leading-edge technology

Analytical method development and validation
Full raw material release and USP <1> injectable testing for finished goods
Stability testing across all ICH Zones for impermeable and semi-permeable containers
Testing for residual solvents, elemental impurities, extractables & leachables, photostability, nitrosamines and container closure integrity, nitrosamines and thermal cycling

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Manufacturing Services

Advanced sterile filling systems to support diverse container types and batch sizes

Formulation scale of 1 L to 4000 L using stainless steel and single-use technology
Fully isolated filling lines for vials, syringes and IV bags, including drug-device combination products
Automated visual inspection, assembly, labeling, packaging, and serialization

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The kind of expertise you have to experience

With more than 20 years of quality and compliance experience, VP of Quality Mike Scribner has an extensive history of leading teams to successfully develop regulatory submissions across a variety of products. His degree in biology, MBA, quality engineer certification, and regulatory affairs certification mean that he knows exactly what it takes to deliver high quality medical products.

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