Custom API Development

We offer a comprehensive range of customized small molecule API capabilities, including route selection, process development and optimization, as well as analytical development and validation. Custom API development is aspect for the pharmaceutical industry. APIs are the key components of a drug responsible for its therapeutic effects. Custom API development involves synthesizing new APIs based on specific requirements or enhancing the properties of existing APIs.

QC/Analytics

Analytical method development, ICH method validation, cleaning verification, ICH stability studies.
API Manufacturing

FDA/MHRA/AIFA-approved facilities, rapid & safe process scale-up, pre-clinical to commercial production, controlled substances(all schedules), oligonucleotides (ASOs & siRNAs).
Process Validation

Ongoing process verification, process performance qualification, process control strategy, process characterization & CPP (Critical Process Parameters) studies.
Process Development

Process safety assessment, process design & optimization, process transfer to plant, QbD (Quality by Design)/DoE (Design of Experiments), and PAT (Process Analytical Technology) methodologies.
Solid-State Chemistry

Polymorph screening, salt & co-crystal screening, crystal engineering, crystallization process development.
Route scouting, IP generation, cost of goods analysis

Top-tier synthetic chemists, extensive online chemistry resources, innovative chemistry tracking record.