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SG BioSciences partners with pharmaceutical and biotech companies to strengthen their quality frameworks and proactively manage risks. Our expertise helps organizations maintain audit-ready operations, improve manufacturing reliability, and meet regulatory expectations without disruptions. From acting as your extended quality team to implementing a structured risk assessment approach, we bring hands-on support with a focus on continuous improvement and compliance assurance.
Custom compliance frameworks for U.S., EU, and nuclear regulatory authorities. Plans focus on understanding specific rules for each region, avoiding common errors, and preparing full documentation. It helps manufacturers stay inspection-ready and reduces the chances of delays or penalties.
Gap assessments, SOP development, and training to help you pass audits with confidence. We cover all areas auditors check, from process records to safety checks. Step-by-step guidance helps avoid mistakes, strengthen systems, and meet all quality and safety inspection points.
Integration of global safety standards, including radiation-specific protocols for radiopharma. Includes setting up safe handling practices, equipment checks, and reporting systems. Helps meet global health standards while keeping people safe in radioactive work environments.
Technical and scientific support for compiling and submitting radiopharma-specific eCTD modules. Our support covers file formatting, document tracking, and avoiding common submission errors. Makes the regulatory filing process easier and more organized for faster approvals.
We offer a comprehensive suite of quality management services, functioning as a dedicated quality unit to ensure product integrity, regulatory compliance, and operational excellence. Our support includes:
Our risk management services ensure that validation processes are proactive, robust, and compliant. We help clients identify, evaluate, and mitigate risks using a structured framework that includes:
Need expert support to elevate your quality systems and reduce operational risk? SG BioSciences works alongside your teams to build sustainable, compliant processes that hold up under regulatory review and improve long-term performance. Let’s get quality right, every time.
We do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected status.
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