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SG BioSciences provides comprehensive validation consulting services to help pharmaceutical and biotech companies maintain audit-ready environments and achieve consistent product quality. From equipment qualification to process and software validation, we bring technical rigor and regulatory insight to every engagement.
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.
Establishing validated, reproducible manufacturing processes that meet FDA and EMA expectations. We support teams in documenting process steps, setting cleaning methods, and checking repeatability to make sure everything works as expected before your product goes to market.
Full lifecycle validation services including installation, operational, and performance qualifications. We help with setup and testing of equipment to confirm it works properly, meets user needs, and continues to function reliably over time, reducing the risk of production issues.
Validating GxP-regulated systems using risk-based approaches and data integrity best practices. We guide teams in making sure their software systems are set up, tested, and maintained in a way that ensures accurate records, reliable access, and compliance with global standards.
Authoring master plans, protocols, and final reports aligned with global compliance standards. We help teams create easy-to-follow templates, checklists, and final documents that make audits smoother and ensure all validation steps are properly recorded and tracked.
Preparing teams and documentation for FDA inspections with mock audits, gap analysis, and CAPA strategies. We support readiness with checklists, trial run inspections, and advice to fix gaps—helping teams feel confident before an audit or regulatory review.
Need help getting validation right the first time? We work with your teams to set up smooth, compliant processes—so you’re prepared before any inspection or system goes live.
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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