About Amicus
Changing the consulting experience for FDA-regulated businesses.
Changing the Consulting Experience for FDA-Regulated Businesses
Amicus is a Good Manufacturing Practice (GMP) consulting firm that works with FDA-regulated companies to help them achieve regulatory compliance and avoid FDA scrutiny. We identify issues and create customized solutions so our clients can maintain the highest level of quality and safety.
Amicus was born out of a desire to change the consulting experience for FDA-regulated industries. Our founders saw a big gap in the market: many consultants could identify problems, but few could provide solutions.
We created Amicus to fill that gap, to provide expert guidance as well as hands on support to implement lasting change. We help businesses in the pharmaceutical industry navigate the complexities of compliance with confidence.
Team Experience
Our leadership team brings over 125 years of combined experience, with deep regulatory, manufacturing, and quality expertise tailored to real-world operations in FDA-regulated industries.
Leadership Team
Amicus is led by Kristopher Le, PharmD, CEO and Founder; Becca Mitchell, PharmD, Principal, Quality and Regulatory; Don Carter, Principal, Validation; and Jamie Duncan, CQA, Principal, Quality. A principal leads every engagement.
How We Work
We work as a partner to FDA-regulated organizations, helping our clients identify opportunities for improvement, implement lasting solutions, and turn compliance challenges into sustainable growth. Our approach is hands-on and solutions-focused. We act as an extension of your team rather than simply producing audit reports, and we work with pharmaceutical companies, suppliers, CDMOs, and clinical sponsors across all stages of development and commercialization.
Mission
Our mission is to help companies in FDA-regulated industries identify areas for improvement in their facilities and processes to comply with regulations, improve patient safety, and increase business profitability. We don’t just provide a list of issues; we provide solutions that align with each client’s goals and capabilities.
Our Values
Built on a foundation of innovation, excellence, honesty, and transparency, we help clients achieve reliable, sustainable compliance and business growth.
Kristopher Le, PharmDCEO & Founder
Meet the Amicus Principals
Every engagement is led by a named principal.
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.
VP Quality AssurancePharmaceutical Manufacturer
Amicus provided hands-on support as we scaled our manufacturing operations. Their consultants worked closely with our team to improve documentation, refine procedures, and ensure our systems aligned with cGMP expectations.
Head of ManufacturingBiotech Company
The validation support from Amicus was excellent. Their team brought real-world CQV experience that helped us commission our new facility on schedule while staying aligned with our validation master plan and regulatory expectations.
VP Technical OperationsCDMO
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.