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Clinical-and commercial-ready small-molecule manufacturing with robust QA/QC,data integrity (ALCOA+),and risk-based control across development to scale-up.
From early clinical to commercial supply with tech transfer.
Regulatory-ready reagents, buffers, excipients and adjuvants.
Bioconjugation and complex chemistries with controlled environments.
Ensuring equipment performance through systematic qualification and regular calibration.
Maintaining GMP compliance via continuous monitoring and validated cleaning processes.
Securing product quality through temperature-controlled storage and compliant distribution.
Identifying and mitigating process risks to ensure safe and reliable operations.
Ensuring all operations strictly follow GMP, ISO, and regulatory standards to maintain consistent quality, traceability, and customer confidence.
Pharmaceutical Quality System aligned with ICH Q10 and cGMP
Deviations, investigations, change control and CAPA management
ALCOA+ data integrity (attributable, legible, contemporaneous, original, accurate; plus complete, consistent, enduring, available)
Method development/validation/transfer; release testing and stability
