Comprehensive Regulatory Compliance and Approvals
Our Regulatory Affairs Department works with a variety of U.S. and international regulatory bodies and is prepared to take your project through any compliance or approval processes necessary to drive it to market. All clients are notified of inspections, facility shutdowns, new product protections, and any major facility changes through an online client notification system to rapid communication.
Your Partner in Regulatory Compliance
The regulatory team assigned to your project has access to all information developed through all stages during development and will be in touch with your organization’s regulatory group to ensure that the Chemistry, Manufacturing and Control (CMC) documentation package contains all components requested by the client. Our regulatory team offers ongoing support to your internal department for any documentation submitted in support of your project’s CMC section. Our regulatory teams have assisted our clients with over 100 products resulting in numerous product approvals.
Regulatory Documentation Processes
Regulatory Affairs coordinates the assembly of client products and process related documentation suitable for the client’s preparation of regulatory submissions. Support documentation includes manufacturing process summaries; component, process and personnel flow diagrams, client specific equipment and process validation summaries.
Documentation submitted to the client generally contains Master Batch Production Records and batch specific Batch Production Records. Jubilant HollisterStier recognizes that each client has unique needs but ensures consistency in our CMC support through the use of templates that are in alignment with common CTC sections.
Kenya Health Authority
Stay Up to Date with JHS
JHS acquired the tech transfer for a COVID-19 liquid suspension vaccine product that was approved for use internationally, but not within the US.
Jubilant HollisterStier LLC announced that it has received the prestigious CMO Leadership Awards 2022 in five categories – Expertise, Capabilities and Compatibility across small pharma respondents and Service and Reliability across overall respondents and small pharma respondents.
Jubilant HollisterStier Contract Manufacturing is pleased to announce the appointment of Ian Fuller as the new Vice President of Operations.
Elevating Your Vision with Personalized Support
Contact us today and let’s explore how we can support your next project.