Regulatory Affairs a Competent Partner Helping to Ensure Regulatory Compliance
Because differences exist between regulatory agencies from region to region, West regulatory affairs continually stays informed of new developments and changes in order to provide customers with accurate regulatory support regarding packaging requirements.
With a keen understanding of various regulatory agencies’ positions specific to our products, West’s regulatory affairs team offers unparalleled global submission support. In particular, West specializes in Common Technical Document (CTD) sections 3.2.P.7 for container closure systems, as well as 3.2.P.3.5 for process validation and 3.2.P.3.3 for process description related to wash and sterilization processes.
In the United States and Canada, West offers Drug Master Files (DMFs) for:
- Rubber formulations and coatings
- Westar® RS/RU processes
- Westar® lined seals process
- NovaPure® components
- Daikyo Crystal Zenith® systems
West also provides a Letter of Authorization/Access to DMFs and responds to agency requests either confidentially or non-confidentially, where the response goes directly to the customer.
Knowing regional differences not only helps to navigate the regulatory process, but ultimately strengthens the composition of submission dossiers. West customers can trust that our regulatory team has the knowledge and the experience to deliver a complete submission within the respective region or country.
Please check back for upcoming blogs to learn more about West’s specialized experience with food compliance, animal derived substances and natural rubber/latex.
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.