At Syner-G, our Functional Outsourcing Partnership team is dedicated to enhancing your regulatory efforts through expert collaboration. Our specialized regulatory personnel integrate seamlessly with your team, providing comprehensive support for global programs and submissions from inception to completion. This collaboration ensures a smooth, efficient, and cohesive regulatory process throughout.
The Syner-G Advantage
Diverse Expertise
Our team consists of highly skilled professionals ready to assume both strategic leadership and tactical support roles. We bring extensive experience in:
- Development and post approval processes
- Managing a variety of product types such as small molecules, large molecules, combination products, and medical devices
- Navigating complex regulatory landscapes across multiple jurisdictions
Proven Processes
We pride ourselves on our:
- Robust internal governance model that supports highly effective project teams
- Strong track record in the rapid onboarding and training of crucial team members, ensuring readiness and efficiency
Our Core Services
Global Post Approval and Product Lifecycle Management
We offer end-to-end support in regulatory and lifecycle management, crucial for maintaining compliance and maximizing product potential. Services include:
- Strategic regulatory impact assessments of change controls
- Authoring of critical sections of impacted global marketing applications
- Comprehensive lifecycle strategy development aligned with your business goals
Market Expansion
Expanding into new markets is facilitated by our adept handling of:
- CMC submission strategies tailored to specific regulatory environments (US, EU, Japan, China, LATAM, etc.)
- Prompt and comprehensive responses to regulatory agency inquiries
- Management of essential regulatory documents and certifications
Execution-Ready Team
Our ready-to-deploy teams are:
- Trained to integrate with your operations without disruption
- Equipped to manage complex regulatory challenges swiftly
- Focused on maintaining stringent quality control and data integrity through rigorous reviews
Partnership Success Factors
Governance
- Functional meetings with Client Sourcing Lead
- Client Product Lead meetings (i.e., small molecule, biologics, device)
- Strategic Review Meetings with Client Senior Management
Train the Trainer Model
- CMC expert provides oversight and advice on strategy and content
- Buddy system: partners train new hires/junior colleagues
- Routine team meetings offer continuous learning
Flexible Resourcing
- Cross training of team members
- “Swing capacity”/ reserve resources onboarded and ready to start with short notice
Transparency
- Customized Project Trackers and Dashboards provide visibility to Project status, Utilization, and Change controls
- Syner-G can author job aid to define roles and responsibilities
Quality & Continuous Improvement
- Continuous improvement via weekly team meetings and feedback from client
Why Choose Syner-G?
With Syner-G, you gain a partner who is as committed to your project’s success as you are. Our functional outsourcing solutions are designed to be an extension of your team, leading to enhanced outcomes and streamlined processes. Contact us today to see how we can help take your project to the next level.