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.
Our 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
At Amicus, our values are the foundation of everything we do.
Quality and Safety
We never compromise on quality and safety. Every solution we provide exceeds industry standards.
Collaboration
We become part of our clients’ teams, working together to help them achieve their business goals while remaining compliant.
Customized Solutions
We don’t do one-size-fits-all solutions. We tailor our recommendations to each client’s unique needs and constraints.
What Sets Amicus Apart
Amicus isn't your average GMP consultant.
Many times, consultants identify problems in your organization but offer no real solutions. Even worse, they may give you a roadmap designed for a completely different company with different capabilities or resources.
At Amicus, we don’t just identify problems in your business. Instead, we provide and help implement solutions that stand up to FDA scrutiny.
Expertise
Hands-On Solutions
Client-Focused
Reliable
How We Do It
At Amicus, our process is collaborative and thorough.
We start by conducting a comprehensive GMP audit to identify any areas of noncompliance.
Then, we work with our clients to develop solutions to achieve compliance and the client's unique goals with their capabilities. We also support our clients as they implement these solutions.
Our commitment to quality assurance and regulatory compliance means our clients can trust us to help them navigate regulatory inspections and industry best practices.
Get to Know Our Team
Our team at Amicus consists of expert GMP consultants. Each of us has years of experience and a dedication to developing long-term partnerships with our clients. We provide GMP consulting services, staff augmentation, and vendor qualification to help our clients succeed.
Kristopher Le
Becca Mitchell
