Afton Scientific is a highly-experienced cGMP CMO specializing in sterile injectables.
We can Formulate, Aseptically Fill, Label, and Package your small-batch parenterals. Our customers include major global pharmaceutical companies and emerging biotechs.
Sterile manufacturing services offered
Clinical Trial and Commercial Drug Products
Both Small and Large Molecule
Inspected by Both CDER and CBER
International Standards – FDA, PMDA, MHRA, and EMA
Terminal Sterilization
Engineering and Formulation Scale-Up
Commercial Batch Record Development
Technology Transfer
Analytical Support
Regulatory Filing Assistance
Label/Pack/Serialization
Our flexibility allows us to get client projects on the schedule as quickly as possible and maintain robust regulatory compliance. Quality assurance and in-house analytical services allow us control over product release timelines to ensure that products hit the market or clinic on time. Our facilities can handle vial sizes from 2mL – 100mL and batch sizes from thousands to tens of thousands making us an ideal fit for small-run commercial drugs and clinical trial materials.
We can Formulate, Aseptically Fill, Label, and Package your small-batch parenterals. Our customers include major global pharmaceutical companies and emerging biotechs.
Sterile manufacturing services offered
Clinical Trial and Commercial Drug Products
Both Small and Large Molecule
Inspected by Both CDER and CBER
International Standards – FDA, PMDA, MHRA, and EMA
Terminal Sterilization
Engineering and Formulation Scale-Up
Commercial Batch Record Development
Technology Transfer
Analytical Support
Regulatory Filing Assistance
Label/Pack/Serialization
Our flexibility allows us to get client projects on the schedule as quickly as possible and maintain robust regulatory compliance. Quality assurance and in-house analytical services allow us control over product release timelines to ensure that products hit the market or clinic on time. Our facilities can handle vial sizes from 2mL – 100mL and batch sizes from thousands to tens of thousands making us an ideal fit for small-run commercial drugs and clinical trial materials.
Focus Areas
BIO DOUBLE HELIX SPONSORS
BIO HELIX SPONSORS
