Expertise across the API lifecycle
Your API demands a process built on precision and trust.
At Pisgah Labs, our development and manufacturing capabilities are designed to bring that balance to your program, combining scientific insight with the operational control needed for reliable scale-up and supply.
Process development and optimization
Our chemists create processes that perform reliably in practice, not just on paper. From early design through transfer, we refine reaction steps to build control and reproducibility, ensuring every route is ready for cGMP manufacturing.
Clinical to commercial manufacturing
Your process scales within an environment built for consistency. Our cGMP, FDA-registered suites, equipped with reactors from 80 to 8,000 liters, support phase-appropriate manufacturing that maintains quality and documentation standards from first batch to market supply.
Unit operations
Purification and isolation steps are executed with the same discipline as synthesis. Each operation — centrifugation, drying, or milling — is validated and traceable, protecting the integrity of your material throughout manufacturing.
Analytical and stability testing
Our analytical team develops and validates methods alongside manufacturing to confirm process control, while stability studies demonstrate that your API performs predictably over time.
To navigate regulatory complexity, we provide complete analytical, CMC and DMF support — giving you confidence from development through submission.
Controlled substance expertise
When your project involves controlled materials and controlled substances, our experience safeguards progress. DEA registration for Schedules I–V, secured storage facilities and established procedures keep your program compliant, secure and inspection-ready from start to finish.
Deeply rooted in quality
Quality defines how we work. It shapes every decision we make and every batch we produce, creating a culture where doing things the right way is second nature.
Our cGMP Quality Management System links science and structure to maintain control and integrity from development through manufacture.
Working closely across functions, our teams ensure each API performs as intended — reliable, compliant and ready to move forward with confidence.
Built for seamless growth from pilot to commercial
At Pisgah Labs, every stage of development is designed with the next one in mind, building the controls, documentation and technical understanding needed for seamless transition from pilot to commercial manufacture.
Our three cGMP suites provide flexible capacity, supported by validated utilities and experienced operators who understand the chemistry behind each scale.
This continuity gives you certainty that the chemistry you prove early is the same chemistry that delivers at scale.
Onyx Scientific | Sunderland, UK
Our U.K.-based sister site, Onyx Scientific, complements Pisgah’s development and manufacturing capabilities by providing process R&D, solid-form development, impurity and reference-standard synthesis, and small-scale cGMP API manufacturing.
Together with large-scale commercial production available through Ipca Laboratories, we offer an integrated development pathway from early materials to commercial supply.