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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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“Overall, Syner-G has been able to prove not only that they have the expertise and industry experience but also that they are agile in their knowledge and are ultimately sophisticated problem solvers.”
- Chief Operating Officer, International Biotechnology Company
“The partnership with Syner-G fulfilled Yumanity’s CMC needs in an effective and efficient manner. The Syner-G team was easy to work with and in this business, that really matters."
- Paulash Mohsen, CBO and head of CMC and Program Management
“Syner-G took ownership of the project as if it belonged to them, making themselves available 24/7 for real-time manufacturing concerns and engaging closely with the FDA on our behalf to satisfy regulatory and quality requirements. They are a TREMENDOUS asset to have. They feel like part of our team; they are a true stakeholder in the success of our programs.”
- SVP, International Biotechnology Company

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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Latest Developments and Insights

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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…

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Understanding the Phases of FDA Approval for Drug Development

Navigating the different phases of the regulatory pathway during drug development to achieve FDA approval is a complex and critical process every new drug must undergo. This process, essential for guaranteeing the safety and efficacy of medications, involves a rigorous…

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