Full cycle drug product manufacturing support

Primary packaging development and qualification
Get support in the selection and qualification of the right primary packaging that is compatible with the drug product formulation.

Development, Tox batch and Reference Standard manufacturing
Accelerate the timeline for IND submission with toxicological studies. Access our state-of-the-art pilot-scale aseptic manufacturing capabilities and our ability to supply high-potent drug products (such as Antibody-drug conjugates) for toxicological study or stability and regulatory purposes.

Technology transfer
Employ a team to design the suitable clinical/commercial manufacturing process for your molecule and generate the required source documents for manufacturing.

GMP manufacturing (biologics drug product) as liquid or lyophilisate
Our team offer you clinical and commercial DP GMP manufacturing, risk assessment and development.

Investigation support
Our experts can support assessments, RCIs and generate data to close out the investigation.

Regulatory expertise
Pathway to success in Regulatory filings
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