Global Submission Support Packages
Global Submission Support Packages are intended to support customers in countries where Drug Master Files (DMFs) have not been established. They provide customers with the technical information for West products and processes needed for inclusion in their drug applications.
Each package’s content is designed to meet Health Authority expectations for pharmaceutical components in drug applications and they are back by West RA support for any follow-up questions you may receive from reviewing agencies.
West currently has packages for the following products and processes:
- Daikyo Crystal Zenith® Cartridge System
- Daikyo Crystal Zenith® Syringe System
- Daikyo Crystal Zenith® Vials
- NovaPure® RS/RU
- Steam Sterilization Process
- Standard Elastomers
- Westar® RS Lined Seals
- Westar® RS Wash process
- Westar® RU Gamma Sterilization Process
- Westar® RU Steam Sterilization process
For more information, contact your Customer Service representative or e-mail West RA at:
Europe/Asia Pacific: firstname.lastname@example.org