Quality & Regulatory
We help clients bring their products to market, and keep them there safely, so they can positively impact the lives of the patients they serve.
Our capabilities include:
483 / Warning Letter / Consent Decree Prevention & Remediation
We partner with clients to prevent regulatory enforcement actions and deliver rapid, effective remediation when findings occur—driving durable corrective actions and restoring regulator confidence.
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FDA Observation Assessment and Response Planning
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CAPA Planning, Investigations, and Execution
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QMS Remediation
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Supplier Quality Audits
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Post-Market Surveillance Backlog Reduction
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Deviation Management
Regulatory Affairs Submissions
Our regulatory experts manage and support global submissions, ensuring accurate, timely, and compliant dossiers that align with evolving agency expectations and business objectives.
- Domestic Submissions (IND, NDA, CMC, BLA, ANDA, 510K, IDE)
- Global Submissions (CTA, MAA, NMPA, PMDA, CE Marking)
- eCTD Expertise
- Regulatory Project Management and Strategy
- Post-Market Reporting (PMS, Safety, Adverse Event, PAS, PMC, Recalls)
GCP & GMP Compliance
We help organizations design, assess, and remediate GCP and GMP programs to ensure inspection readiness, data integrity, and sustained compliance across the product lifecycle.
- Audits and Gap Analysis
- SOP Creation and Harmonization
- Computer System Validation (CSV)
- Process Engineering and Process Optimization
- Document Control
Risk Management Guidance
We provide proactive risk identification and mitigation strategies that strengthen quality systems, support regulatory decision-making, and reduce operational and compliance exposure.
- Cross Functional Strategy and Guidance
- Risk Management Planning
- Risk Assessment Strategy and Execution
- Design Control and Change Management Evaluation
- FMEA
Licensing, Packaging & Labeling Approvals
Our teams support end-to-end licensing, packaging, and labeling activities, ensuring regulatory alignment, accurate content, and timely approvals across global markets.
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FDA and Global Labeling and UDI Compliance
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Labeling, IFU, Carton and Insert Assessments, and Change Controls
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Labeling Component Preparation and Submission Support
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End-to-End Labeling Strategy
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Cross-Functional Project Management
A Record of Success
Quality & Regulatory Resources
Learn more about our solutions for your company.
