Quality Systems
Comprehensive quality management systems for biotech and life sciences companies seeking regulatory compliance.
Navigating the regulatory landscape in biotech/biopharma requires robust quality management systems that meet stringent FDA, ISO, and GMP standards. Our quality systems consulting brings decades of hands-on experience to help you build, improve, or remediate your QMS.
We work with organizations at every phase — from startups establishing their first quality framework to established companies looking to modernize or address compliance gaps. Our consultants understand that quality systems must be practical, controlled, and sustainable, not just compliant on paper.
Every engagement begins with a gap analysis to understand your current state and current regulatory requirements, followed by a prioritized roadmap that balances compliance needs with business realities.
Key Benefits
- Quality management systems that meet FDA, ISO, and GMP requirements
- Gap analysis and prioritized remediation roadmaps
- SOP development and document control system setup
- Training programs that build internal quality culture
- Ongoing compliance monitoring and continuous improvement support
Frequently Asked Questions
What regulatory standards do you support?
We support FDA 21 CFR Parts 210, 211, and 820, ISO 13485, ISO 9001, cGMP, and related standards. Our team stays current with evolving regulatory guidance to ensure your systems remain compliant.
How long does it take to set up a quality system from scratch?
A foundational QMS for a startup typically takes 3 to 6 months, depending on scope and regulatory requirements. We prioritize critical elements first so you can begin operations while the system matures.
Can you help with an existing QMS that needs improvement?
Absolutely. Many of our engagements involve improving or remediating existing systems. We start with a gap analysis to identify specific deficiencies and create a targeted improvement plan.