CDMO Services for API Design & Development

Q: What types of CDMO services does Neuland Labs offer?

Neuland Labs provides an end-to-end continuum of customized services from early-stage drug development (Pre-IND) through to commercial manufacturing of complex APIs, including process development, process optimization, analytical testing, and regulatory support.

Q: How does Neuland Labs ensure regulatory compliance?

Neuland Labs has a team of experienced regulatory specialists who provide CMC (chemistry, manufacturing and controls) services (w.r.t drug substance / active pharmaceutical ingredient) that seamlessly integrate drug development with regulatory submissions while ensuring compliance with the latest regulatory standards.

Q: How can I work on early-stage drug development with Neuland Labs?

Neuland Labs provides full-cycle development and manufacturing solutions. The extensive team is equipped to tackle obstacles at every stage of the process throughout the entire development journey as part of your extended team.

Q: Can Neuland Labs handle high-volume commercial manufacturing?

Neuland Labs’ versatile CDMO manufacturing capacities are equipped to manage unexpected demand fluctuations throughout the duration of a clinical trial, from small batches to large scale cGMP manufacturing. The facilities support technology transfer, custom API development, scale up and validation batches, analytical services, and stability studies.

Comprehensive CDMO for Pharma & Biotech Industry

We are experts in the custom development and manufacturing of new chemical entity (NCE) APIs for pharmaceutical and biotech companies bringing new innovations to the market. Together we are sharing a healthier, brighter future through our commitment to innovation, quality, and care.

We help handle a range of chemistry services from pre-IND through manufacturing that includes small-scale clinical trial quantities as well as full-scale commercial supplies with minimal tech transfer timelines. Our services encompass designing and developing manufacturing processes; process optimization for competitiveness; cGMP manufacturing of APIs and intermediates; filing of CMC (chemistry, manufacturing and controls) documentation/DMF for the API; and solid-state and pre-formulation technologies. This enables us to serve as a complete partner to our customers.

Neuland Labs’ CDMO Services are focused on advancing and supporting chemistry requirements from early stage to commercial manufacturing, including process development, process optimization, analytical testing, and regulatory support.

Custom Development

As a team of 360+ R&D specialists, we have the capabilities to custom develop advanced new chemical entities from molecule through to clinical development and commercial-scale supply with minimal tech transfer timelines.

Custom Manufacturing

We have three cGMP-certified facilities with state-of-the-art equipment for producing APIs and intermediates for Phase I through large Phase III clinical trials. We collaborate closely with customers to overcome the challenges of commercial manufacturing.

Peptides

Our expertise covers the commercial production of high-purity peptides, including solid-phase peptide synthesis, solution-phase peptide synthesis, and hybrid technology for complex peptides.

Neuland works to understand our manufacturing process and develops process improvements. The team carefully considers alternatives and implement optimizations.