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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

Our selection process involves a deep understanding of your drug development goals, risk tolerance, and the specific needs of your pipeline. By prioritizing compatibility and operational excellence, we identify CDMO partners that are best equipped to handle the complexities of your project. This approach ensures seamless integration with our high standards, facilitating a smooth transition from development to commercial scale.

Accelerated Development through Strategic Partnerships

Traditional CDMO selection processes often lead to extended timelines from IND planning to first patient dose, typically ranging from 18-24 months. Syner-G employs a more dynamic approach, leveraging accelerated CMC strategies that significantly reduce these timelines to 9-12 months. This efficiency is achieved by initiating parallel development activities and optimizing each phase of the production process, ensuring faster time to market without compromising quality.

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:

CDMO Library
Utilize a comprehensive library of CDMOs to filter candidates based on specific service and project needs.
Interest and Confidentiality
Approach CDMOs to gauge interest and establish Confidential Disclosure Agreements, ensuring all parties are aligned from the outset.
Request for Proposals (RfPs)
Narrow down the list of potential partners and send out RfPs to solicit detailed proposals.
Proposal Evaluation
Use a standardized model to perform an "apples to apples" comparison of received proposals.
Scoring System
Employ a weighted scoring system to objectively evaluate the attributes of each CDMO.
Negotiations and Final Selection
Engage in critical negotiations focusing on factors that make a partnership appealing to both sides and finalize the selection based on strategic fit and operational excellence.

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

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.