Late-phase and commercial

Late-phase and commercial

Our services span from pre-Clinical stages to First-in-Human supplies, ensuring seamless progression with GMP-compliant batches. We specialize in Tox Batches and FIH GMP Batches, leveraging cutting-edge technology to meet rigorous safety and efficacy standards, setting a solid foundation for successful clinical trials.
Tech Transfer

Tech Transfer

At LAXAI, our tech-transfer process is meticulous, ensuring a smooth transition from development to commercial-scale manufacturing. Our team specializes in adapting processes to new environments while maintaining product quality, efficiency, and compliance with regulatory standards.

Process Validation

Process Validation

Process validation is a key aspect of our manufacturing services, ensuring that every production run meets the predefined quality criteria. Our validation processes are robust and comprehensive, covering everything from initial design to routine production, guaranteeing consistency, safety, and efficacy of the pharmaceutical products.

Regulatory Filing

Regulatory Filing

Our regulatory filing services streamline the approval process for pharmaceutical products. Our team of experts navigates the complex regulatory landscape, preparing and submitting the necessary documentation to regulatory bodies, ensuring compliance and timely approval.

Infrastructure and Instrumentation