Compliance Is Required.
Execution Is Everything.
Hands-on quality, validation, and clinical development partners, from FDA 483 remediation to facility startup.
125+ years combined experience|89 clients supported|8 industries served
Trusted by 503B facilities, CDMOs, and clinical-stage biotech.
Talk to a GMP consultant this week.
The first call is discovery, no confidential details needed. We sign a CDA before any detailed review.
Pharmaceutical ManufacturingBiotech503B Outsourcing FacilitiesCDMOsClinical-Stage Sponsors
Comprehensive Quality & Compliance Services
Three practice areas, one accountable team. Every engagement is led by a principal.
Consulting
Quality systems, inspection readiness, and remediation.
- Quality system development & optimization
- Audit and inspection preparation
- FDA 483 & Warning Letter remediation
- Risk assessments & gap analysis
- Strategic compliance planning & training
- Quality Management System (QMS) frameworks
- CAPA & deviation management
Validation
Commissioning, qualification, and validation across the lifecycle.
- Facility & Equipment CQV
- Cleaning validation
- Computer system & software validation (CSV)
- IQ/OQ/PQ protocol development & execution
- Process & product validation
- Temperature mapping & shipping studies
- Validation master planning & lifecycle management
Clinical Development
Phase-appropriate quality for clinical-stage programs.
- Phase-appropriate Sponsor Quality systems
- CDMO qualification & oversight (including audits)
- Drug substance & clinical drug product support
- IMP testing & release authorization
- Collaboration with CMC, Clinical & Regulatory
- Quality review of IND/ANDA submissions
- GCP compliance & clinical site oversight
Why Partner with Amicus?
Experienced Partners
Hands-on partners offering scalable, risk-based compliance support.
- 125+ years combined experience
- Acting as extension of your team
- Focus on audit readiness & patient safety
- Tailored to real-world operations
Solutions-Focused Approach
Moving beyond compliance to deliver lasting solutions and operational excellence.
- Identify opportunities for improvement
- Implement sustainable solutions
- Transform compliance challenges
- Drive long-term quality and success
Meet the Amicus Principals
Every engagement is led by a named principal.
Kristopher Le, PharmD
CEO & Founder
Operational strategy, process optimization, quality remediation and validation for FDA-regulated organizations.
Don Carter
Principal, Validation
Facility commissioning, equipment qualification and process validation, with over 15 years of industry experience.
Jamie Duncan, CQA
Principal, Quality
Nearly a decade in pharmaceutical quality, compliance and operations within highly regulated environments.
Becca Mitchell, PharmD
Principal, Quality & Regulatory
A founding member of Team Amicus, licensed in 17 states, with regulatory depth and hands-on manufacturing leadership.
Trusted Partners in Quality & Compliance
Real partnerships delivering sustainable solutions across pharmaceutical and biotech development.
Amicus stepped in during a challenging FDA 483 remediation and worked right alongside our team. Their practical approach and deep knowledge of quality systems helped us resolve observations and strengthen our processes for the long term.
Pharmaceutical Manufacturer
Working with Amicus on a mock FDA audit was a great experience. Their team was thorough, professional, and easy to work with, and they provided clear feedback that helped us better understand regulatory expectations.
503B Outsourcing Facility
Ready to Partner for Lasting Quality Solutions?
Let’s discuss how Amicus can support your organization’s compliance, validation, and quality objectives. Whether you’re launching a new facility, remediating FDA findings, or building quality systems, we’re here to help.