Every molecule we ship is backed by a quality system designed to satisfy the world's most stringent regulators. From raw materials to release, traceability is absolute.
cGMP, ICH Q7, FDA, and EMA-aligned operations with dedicated regulatory affairs support for your filings.
Batch-level genealogy and validated records that follow every product from synthesis to your door.
Risk-based QbD principles embedded from development through commercial supply.
Dual-sourcing strategies and validated cold-chain logistics keep your programs moving.
How we operate.
Batch to batch.
With every order.
Protected.
We define requirements, attributes, and regulatory strategy together.
QbD-driven development sets and locks the parameters that matter.
GMP production with in-process controls and independent QA oversight.
Full testing, documentation, and validated delivery to your site.
Yes. We operate to GMP and cGMP standards with ISO-aligned quality systems across our peptide and oligonucleotide manufacturing.
We build data integrity into every batch using ALCOA+ principles, controlled records and traceability, producing audit-ready documentation.
Yes. Our batch records and documentation are maintained to be audit-ready and to support client and regulatory inspections.
Our quality systems are aligned to GMP/cGMP and ISO standards; current certifications and registration details are available on request.
Talk to our quality and regulatory team about your program's requirements.