We are excited to announce the merger of Syner-G BioPharma Group and Sequoia Biotech Consulting, joining forces to deliver integrated solutions for life sciences.
Read the Press Release | Learn more about Sequoia
We are the world's leading CMC, Regulatory Affairs, and Medical Writing solutions provider for biopharma.
About Syner-g
Who We Are
What We Do
Pharmaceutical Development (CMC)
Pharmaceutical Development (CMC)
Regulatory Strategy & Submissions
Regulatory Strategy & Submissions
Functional Outsourcing Partnerships
Functional Outsourcing Partnerships
Medical Writing
Medical Writing
Quality & Compliance
Quality & Compliance
Our Capabilities
Why Syner-G?
Number of Years of Industry Experienced Sr. Consultants
Number of Employee and
Number of Ph.Ds World-wide
Number of INDs and IND Amendments Filed
Number of Post-Approval Major Supplements
Years As An Organization (aggregate across all Syner-G companies)
Assets Supported
Number of Agency Meetings
Careers
Latest Developments and Insights
CMC Safety and Efficacy in Gene and Cell Therapies
Gene and cell therapies are at the forefront of medical breakthroughs, offering new possibilities for treating complex diseases. The success of these therapies heavily relies on the meticulous processes involved in Chemistry, Manufacturing, and Controls (CMC). CMC plays a crucial…
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The Evolution of US Biologic Drug Regulations
In the first instalment of our multi-part series, the key differences between biologic drugs and traditional small molecule drugs such as active pharmaceutical ingredient source, molecular size, structural complexity and immunogenicity were introduced. In this second instalment, we explore the…
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Navigating the Evolution from ICH Q2(R1) to ICH Q2(R2) and Implementation of ICH Q14 in Biopharmaceutical Method Validation
In the dynamic landscape of biopharmaceutical development, adherence to evolving international standards is crucial. The recent updates from International Council for Harmonisation (ICH) Q2 “Validation of Analytical Procedures” from Revision 1 to Revision 2, coupled with the introduction of ICH…