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At Syner-G, our dedication to scientific thought leadership and strategic innovation stands at the core of our mission to redefine the pharmaceutical industry. We combine rigorous scientific research with keen market insights to emerge as a leading consultancy in drug development. Our approach is meticulously designed to foster innovation and drive excellence, ensuring that we not only meet but exceed the complex demands of today’s global healthcare landscape.
Selecting the right Contract Development and Manufacturing Organization (CDMO) is pivotal to the success of our pharmaceutical development efforts. At Syner-G, our strategic approach ensures that each CDMO aligns perfectly with both CMC standards and broader corporate objectives, embodying our commitment to quality, reliability, and scalability. This meticulous vetting process not only enhances project integration and execution but also optimizes the efficiency and success of the entire development pipeline.
Strategic Vetting for Excellence
Accelerated Development through Strategic Partnerships
Comprehensive Document Preparation Services
Our six-step selection process is designed to streamline the vetting of potential CDMOs, ensuring that we partner with organizations capable of meeting the specific requirements of your project:
Developing Complex Biologics as Therapeutic Modalities
Key Considerations in Negotiations
When negotiating Master Service Agreements (MSAs) and Quality Technical Agreements (QTAs), it is crucial to address several key considerations:
Regulatory compliance capabilities of the vendor:
- Clear assignment of responsibilities
- Vendor’s willingness to host quality assessments
- Sponsor’s responsibilities in meeting the vendor’s requirements, particularly when a Qualified Person (QP) is involved
QA and Vendor Selection Impact
Quality Assurance (QA) plays a crucial role in vendor selection, impacting various aspects:
- Regulatory Requirements: Ability of vendors to provide necessary regulatory information
- Supply Chain: Clear delineation of responsibilities impacting cost and timeline
- Documentation: Timely provision of essential manufacturing/testing documentation
- Release Process: Requirements for specific process and batch information, especially critical when a QP is involved
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At Syner-G
Our integrated approach to pharmaceutical development and CDMO selection ensures that your projects are not only compliant but also set up for success, maximizing efficiency and aligning with strategic business objectives. Connect with us today to leverage our expertise in navigating the complexities of CDMO selection and pharmaceutical development.