Solving Problems & Creating Solutions for FDA-Regulated Industries
At Amicus, we know how tough it is to operate in the pharmaceutical industry, as well as healthcare providers and other FDA-regulated industries. Our mission is to help your business navigate those complexities so you meet compliance and thrive in your industry. We focus on your industry needs and deliver customized solutions to protect your operations from regulatory risk.
Whether you’re a pharmaceutical manufacturer, a 503b outsourcing facility, a large hospital, or a cannabis manufacturing and processing facility, Amicus is your partner. We have expertise across many industries and deliver results that increase efficiency, productivity, and profitability in your manufacturing process.
Industries We Specialize In
At Amicus, we offer services to help your business meet FDA compliance requirements and maintain the highest drug quality. Our solutions are designed to combat the specific challenges of FDA-regulated industries and larger health systems.
503b Outsourcing Facility
The 503B industry is constantly changing, so you need a partner who is up to date on regulations and industry best practices. Trust us to keep you ahead of the regulatory curve.
Large Hospitals
We serve community health systems and more independent hospitals looking to provide patients with the best care. We can help even the largest health systems by auditing 503B providers or by assisting with your goals to develop an in-house 503B or compounding program.
Pharmaceutical Manufacturing (Sterile & Non-Sterile)
Pharmaceutical manufacturers have many processes that must comply with FDA guidelines. We’ll ensure that your pharmaceutical development is compliant on every level, from development to delivery.
Cannabis Manufacturing & Processing Facilities
In the Cannabis industry, there are strict quality-control guidelines and ethical standards that cannabis manufacturing and processing facilities must uphold. Trust us to ensure that you’re delivering quality drug products.
How We Transform Challenges Into Solutions
Know Your Goals
Analysis and Discovery
Customized Solution Design
Implementation Assistance
Ongoing Monitoring and Maintenance
Frequently Asked Questions
We work with both large and small companies in a variety of industries, including but not limited to 503b outsourcing facilities, pharmaceutical manufacturing companies, large hospital systems, and cannabis manufacturing facilities.
Our experts are current with FDA regulations and industry best practices. We analyze and design customized solutions to ensure your operations are compliant.
While other consultants may just identify problems, Amicus provides solutions specific to your industry and business. We focus on compliance with good manufacturing practices and operational efficiency so you can achieve long-term success and avoid negative action from the FDA.
Yes, we can work with your existing GMP consultant or take over to provide more comprehensive and customized solutions that meet your business goals and industry needs.
Working with Amicus means you’ll be FDA-compliant, more efficient, and more profitable. Our solutions are designed to address your industry challenges and grow your business while helping you avoid FDA scrutiny.
Let's Start Finding Solutions for Your Industry.
Contact Amicus today to develop a plan of action for your industry and business.
