We Ensure Quality & Safety
If your business violates FDA regulations, you’re at risk of facing serious consequences. At Amicus, we create solutions that prevent negative FDA action and improve your business’s profitability with increased efficiency, scale, and compliance.
Our Services
Solutions that stand up to FDA scrutiny
Quality Assurance
The right processes and people
Audits
Ensuring compliance & continuous improvement
Project Management
Assistance with large and small projects
Production Process Development
Assistance with GMP product development
Regulatory Affairs
Providing support where you need it most
Facility Design & Automation
Ensuring you meet necessary facility specifications
Process & Equipment Validation & Qualification
Helping you throughout your entire project
Temperature Mapping & Validation
Assisting with protocol development and execution
Industries We Serve
We offer our service for businesses from a variety of FDA-regulated industries, including
503B Outsourcing Facilities
Large Hospital Systems/IDNs
Pharmaceutical Manufacturing
(Sterile & Non-Sterile)
Cannabis Manufacturing & Processing Facilities
Identifying Problems & Creating Solutions
Most other consultants provide a list of problems but no real solutions. At Amicus, we help you succeed by understanding where you want to go as a business, your goals, and the resources you have available. Then, we determine how we can build a customized solution specifically for you to achieve your goals no matter the potential constraints.
We Have a Proven Track Record for Success
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Let Us Help You Every Step of The Way
Contact us to see how we can help you succeed and achieve your goals.
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