Scientific, Regulatory & Quality
Quality & Compliance
Quality systems that support speed and success.
At Syner-G, our commitment to excellence in quality assurance and compliance ensures that every phase of your project is under meticulous oversight.
Our team delivers end-to-end strategic and tactical support, including gap assessments, QMS design and development, clinical and manufacturing quality support, and vendor quality management. We tailor every engagement to create right-sized, phase-appropriate solutions that accelerate timelines while maintaining flexibility and compliance.
Challenges we can help solve:
Difficulty maintaining consistent quality oversight across multiple external partners
We help our partners establish a proactive vendor quality management framework that includes defined quality agreements, risk-based auditing, performance metrics, and transparent communication channels.
Inconsistencies in documentation and analysis of nonconformances
We implement standardized, data-driven nonconformance processes that enable timely investigation, closure, and trend analysis. By combining cross-functional review, targeted training, and digital tools, we help prevent recurrence and foster continuous improvement.
Frequent or recurring deviations in manufacturing, weak process control, and inconsistent employee training
We help clients centralize deviation management within their QMS, simplifying reporting, escalation, and resolution. Using trend analysis, we help our clients build systems and processes that identify issues early and implement preventive measures, while emphasizing regular employee training.
Reliance on outsourced operations when quality systems may not fully account for oversight and ownership across partners
We design sponsor-centric quality systems that clearly define ownership, communication, and documentation expectations between sponsors and partners.
Quality is viewed as the responsibility of QA rather than an organization-wide value
We help clients make quality a shared responsibility through engaged leadership, clear metrics, and cross-functional collaboration.
Client Return Rate
Assets Supported
INDs Filed
NDAs / BLAs Filed
Uphold your brand’s integrity and time-to-market.
Our Approach
Dedicated to quality and compliance — every step of the way.
We specialize in building a culture where quality is everyone’s responsibility—helping teams deliver safe, effective products to patients faster.
From establishing quality systems to solving complex compliance challenges or scaling existing quality systems to meet new regulations, we’re a trusted and hands-on partner committed to your success.
- Quality Management System: quality manuals, quality policies, standard operating procedures
- Control Documentation: data integrity assessments and remediation
- Quality Operational Support: person-in-plant support, technology transfer, process validation, QA oversight, batch record review and release, compliance monitoring
- Audits & Assessments: qualification, pre-approval inspection readiness, GMP, GCP, GLP, GDP audits
We can help with:
Inspection Readiness
Quality Management System (QMS) Development and Implementation: Policies, SOPs, Training, Change Control, and CAPA
Regulatory Submission Support
Data Integrity Planning and Remediation
Quality Metrics and Performance Monitoring
Quality Agreements and Vendor Oversight
Contamination Control Strategy (CCS)
GMP, GCP, GLP, GDP Audits
GMP Audits: Drug Substance, Drug Product, Analytical Labs, Packaging and Labeling, Storage
GCP Audits: Clinical Research Organizations, Analytical Labs, Clinical Sites, Depots
QA Operational Support: Batch Disposition, OOS Investigations, CAPA Execution, Change Control, Documentation Oversight
GLP Audits: Analytical Labs, Vivariums
Compliance Remediation and QMS Gap Closure
Technical Document Review & Master Validation Plan
A complete, fully-integrated solution.
Discovery Sciences
CMC Strategy & Development
Regulatory Strategy
Medical Writing
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Let's move from science to success.
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