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
We provide comprehensive services in product development, regulatory strategy and submissions, functional outsourcing, medical writing, and quality and compliance, complete with program management and submission support. Our integrated approach navigates our client’s pharmaceutical assets through developmental challenges and the complexities of regulatory filings to ensure timely, high-quality submissions.
What We Do
Pharmaceutical Development (CMC)
Pharmaceutical Development (CMC)
We champion a holistic product development approach where our CMC 360™ embodies our commitment to integrating Chemistry, Manufacturing, and Controls (CMC) with a team steeped in science, regulatory affairs, and engineering expertise. This multidisciplinary collaboration ensures scientific rigor and effective project management, guiding our clients' products from pre-IND to post-approval while tailoring phase-appropriate CMC solutions that uphold patient safety and conform to regulatory compliance for each unique project.
Regulatory Strategy & Submissions
Regulatory Strategy & Submissions
Utilizing a unified team of regulatory experts, we offer full-spectrum services across all regulatory areas—Chemistry, Manufacturing, and Controls (CMC), nonclinical, and clinical—ensuring a cohesive strategy for clients' regulatory journey. This streamlined approach aids in engaging with international regulatory agencies across numerous therapeutic fields, showcasing our dedication to comprehensive regulatory strategies and expert handling of complex challenges.
Functional Outsourcing Partnerships
Functional Outsourcing Partnerships
With extensive experience in development and post-approval phases for products like small and large molecules, combination products, and medical devices, our Functional Outsourcing team operates within numerous regulatory frameworks. By providing dedicated regulatory staff who work in tandem with the client’s team, we support global programs and submissions through an integrated outsourcing model, guaranteeing a streamlined and effective regulatory process from inception to completion.
Medical Writing
Medical Writing
Our seasoned team of medical writers is dedicated to delivering documents that are scientifically accurate and compliant with regulatory guidelines with a focus on clarity and precision. Possessing substantial expertise, our team is adept at crafting a diverse array of regulatory documents spanning multiple therapeutic fields and developmental stages.
Quality & Compliance
Quality & Compliance
Syner-G offers a complete range of Quality & Compliance services, guaranteeing thorough supervision from the position of Quality Head to document management. Our commitment to excellence in quality is mirrored in our comprehensive solutions that embrace the entire scope of Quality & Compliance.
Our Capabilities
Why Syner-G?
Partnering with Syner-G means gaining a partner who embodies a holistic, agile approach, with deep expertise tailored to the uniqueness of each client's project and the intricacies of CMC and regulatory demands. We are adept at crafting clear, concise communications with regulatory bodies, focusing on pertinent information to ensure patient safety and regulatory compliance. Our science- and risk-based, phase-appropriate solutions are designed to efficiently propel drug development or maintain post-approval supply chains, with our CMC 360™ and Regulatory Affairs units working in concert to guarantee that our strategies meet rigorous scientific and regulatory standards.
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Number of Years of Industry Experienced Sr. Consultants
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Number of Employee and
Number of Ph.Ds World-wide
0+
Number of INDs and IND Amendments Filed
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Number of Post-Approval Major Supplements
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Years As An Organization (aggregate across all Syner-G companies)
1,800+
Assets Supported
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Number of Agency Meetings
Careers
Joining the Syner-G team means being at the forefront of revolutionizing healthcare solutions in an environment that not only fosters innovation but also promotes personal growth and values collaborative effort.
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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…