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
0
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
0+
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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The Future of CMC in Cell and Gene Therapy Development
Cell and gene therapy development has entered a transformative era, bringing unprecedented challenges and opportunities in Chemistry, Manufacturing, and Controls (CMC). As these revolutionary treatments progress from clinical trials to commercial manufacturing, the future of CMC in cell gene therapy…
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The Importance of Stability Studies in CMC Compliance
Stability studies are essential to pharmaceutical development, providing the data needed to make sure drugs remain safe and effective throughout their shelf life. These studies evaluate how environmental factors like temperature, humidity, and light impact a drug’s quality over time.…
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Understanding the FDA’s Evolving Expectations for Biopharma Compliance
The biopharmaceutical industry stands at a pivotal intersection of regulatory evolution and technological advancement. Companies that successfully adapt to these changes while maintaining robust compliance frameworks will be best positioned to deliver innovative therapies to patients safely and efficiently. …