We are the world’s leading CMC and Regulatory Affairs 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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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 Importance of Quality in Drug Development with Insights from the FDA Fiscal Year 2023 Report on the State of Pharmaceutical Quality
Overview In the intricate world of drug development, the role of quality cannot be overstated. Ensuring the safety, efficacy, and reliability of pharmaceuticals is a cornerstone of the healthcare industry, as highlighted in the U.S. FDA’s Fiscal Year 2023 Report…
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Why are Biologics Drugs Different
What is a biologic drug and how does it differ from a traditional small molecule drug? Biologic drugs have increasingly provided for broader therapeutic use over the last few decades and this trend is accelerating. As the first part of…
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Why Hire an Experienced CMC Consultant for Your Early Phase Studies
The simple answer is you save money, time and get an exciting new drug to the clinic for patients. What is Regulatory CMC and why do I need to pay attention to this during development? Regulatory CMC is at the…