Regulatory Operations Related to Publishing, Submissions
Manage Regulatory Operations Related to Publishing, Submissions and Regulatory Information Management System for Reduced Total Cost of Ownership
In a competitive market, regulatory operations teams are focused on achieving global growth, which requires redefining their operating model by adopting strategic resourcing where resource requirements for new product approvals can be balanced with the demands of maintaining compliance of established products. As regulatory requirements become more and more complex, requiring more in-depth knowledge and increasing staffing needs, organizations must evolve their regulatory operations operating model to execute with speed and at an adequate scale. Through a flexible team model that combines operational and strategic expertise, Celegence guarantees increased efficiency by providing end-to-end regulatory operations services ranging from product registration to post-approval maintenance.
With our depth of expertise and extensive delivery capability, Celegence can drive sustainable outcomes such as scalable resourcing, faster speed to market, improved compliance, and process excellence.
Celegence Can Help Your Business with the Following Dedicated Niche Offerings
- Global product life-cycle management through RIMS application and related software tools.
- Global regulatory publishing and submission management including marketing authorization, variations, and labeling.
- Proactive end to end data processing related to RIMS with outsourced model.
- Help organizations improve submission quality, regulatory compliance, and adopt new data standards.
- Manage services-based resource staffing and comprehensive training of assigned resources specific to customer processes and tools.
- Meet clients’ geographical needs with flexible working hours.
- Document Formatting and Publishing – Word Style Guides and PDF Navigation
Operational challenges such as cost, resources and quality are managed with clear SLAs and OLAs.
Contact Us
If you’re curious how Celegence can help improve your Regulatory Operations, reach out to us and one of our team members will get in touch with you.