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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

Amicus brings over 100 years of combined experience across its leadership team, offering deep regulatory, manufacturing, and quality expertise tailored to real-world operations in FDA-regulated industries.

Leadership Team

Experienced GMP professionals lead the organization, including Chief Executive Officer and Principal Kristopher Le, PharmD; Jamie Duncan, CQA, Principal of Quality; Don Carter, Principal of Validation; and Becca Mitchell, PharmD, Principal of Quality and Regulatory.

Mission and Positioning

Amicus positions itself as a partner to FDA-regulated organizations, helping clients identify opportunities for improvement, implement lasting solutions, and transform compliance challenges into sustainable growth.

The firm emphasizes a hands-on, solutions-focused approach, acting as an extension of client teams rather than simply producing audit reports, and works 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

CEO and Founder

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.

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.

Our mock FDA audit with Amicus was incredibly helpful. They clearly explained where we had gaps, prioritized the issues, and offered practical ideas for fixing them. It gave our team much more confidence going into future inspections.

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.

Amicus was a great partner when we needed guidance responding to regulatory correspondence. Their team understood how the FDA would likely view the issues and helped us develop a clear, thoughtful response.

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.

Meet the Amicus Principals

Kristopher Le, PharmD

Chief Excecutive Officer & Founder

Don Carter

Principal - Validation

Jamie Duncan

Principal - Quality

Becca Mitchell, PharmD

Principal - Quality & Regulatory

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.

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