Achieve Compliance With Customized Solutions
Follow our six-step process—designed by GMP consultants with years of experience in the pharmaceutical industry.
FDA compliance can be overwhelming, especially when you have to balance it with your business needs and resources. At Amicus, we don’t just identify problems or offer boilerplate solutions. Our good manufacturing practice (GMP) consulting services provide solutions specific to your business that meet regulatory requirements and help you grow.
Our team of certified GMP consultants works closely with businesses in the pharmaceutical industry to develop essential strategies and procedures that pass FDA scrutiny and improve your operations. With our hands-on approach, you can pass regulatory inspections, achieve your compliance goals, and grow your business.
Identify & Solve Problems with Amicus's Consulting Services
At Amicus we don’t follow the process that other consultants use. We don't just hand you a list of problems with no ways to solve them or give you a generic template of solutions that won't fit your business model. We provide and help implement customized solutions that pass FDA scrutiny. Our team of GMP consultants offers a range of services to suit your needs so you can be compliant and grow your business:
Custom Solutions to address your unique business challenges.
GMP Consulting to identify problems and guarantee compliance with FDA regulations.
Quality Assurance to install quality management systems and provide quality documentation to ensure your products and procedures meet and maintain FDA standards.
GMP Audits to identify and provide specific solutions to rectify compliance gaps.
Regulatory Inspection Preparation to help you confidently face FDA inspections with the assurance that your practices and processes are up to standard.
Ongoing Support to help you continuously improve and adapt to regulatory standards.
Our Six Steps to Success
Define
Discover
Design
Decide
Deliver
Develop
Frequently Asked Questions
We serve companies in FDA-regulated industries, including pharmaceutical manufacturing, 503b outsourcing facilities, cannabis product manufacturers, and medical device manufacturers.
We start by assessing your business, goals, customers, and resources. This allows us to develop specific solutions.
We always work collaboratively. If we encounter any challenges, we work with you to fix them and get the project back on track.
We conduct thorough audits and provide regulatory inspection preparation so you’re ready for FDA inspection.
Unlike other GMP consultants who provide generic solutions, Amicus provides our clients with customized, actionable strategies and ongoing support so you can succeed in the long term.
Put Our Methods to the Test
Get started with Amicus today and schedule a consultation to see how our custom solutions can help you navigate FDA regulations and succeed in your business. With our expertise and collaborative approach, you can face the future with confidence.
