Pharmaceutical Quality System Remediation Projects
Develop an action plan for responding to statements of non-compliance, including warning letters and FDA Form 483s. Incorporate our practical remediation solutions into your overall quality system for long-term, sustainable compliance.
In an uncertain world, NSF's remediation expertise helps companies around the globe achieve compliance with optimised, pragmatic and risk-based solutions.
Our team of pharmaceutical consultants includes former FDA and MHRA inspectors, as well as industry experts. We help companies develop strategic plans to address enforcement actions from the FDA, MHRA, Health Canada and other global authorities.
Respond to adverse regulatory inspection findings, build a compliant quality system or implement a remediation plan to prevent problems in the future. We work with you to build a quality system that is sustainable for your business.
Receive a risk-based gap assessment, corrective action plans and ongoing implementation support. We also provide ongoing coaching and mentoring for team members at all levels to ensure your culture changes in a sustainable way.
We use a systems-based approach to compliance and cover all major pharmaceutical subsystems, including:
- Quality systems
- Laboratories
- Material controls
- Facilities and utilities
- Production
- Packaging and labelling
Resources
FDA Inspections and Form 483 Responses: What Companies Need to Know
ArticleAn FDA Form 483 response can influence how inspection findings are classified and what happens next. Drawing on NSF webinar insights from former FDA experts Tamika Cathey and Dr. Julia Marre, this article explains what companies should do within the critical 15-business-day response window and where responses often fall short.
How the QA and QP Talent Market Is Changing in Pharma: Insights from Compliance Unlocked Podcast
PodcastRecruiting and retaining experienced quality and regulatory professionals has become significantly more complex for pharmaceutical and biotech companies.
White Paper: The Global AI Regulation Shift in Pharma Biotech
ArticleHow life science leaders must prepare for AI-enabled regulators across the EU, UK and the United States.
How NSF Can Help You
