Turning Challenges Into Opportunities for Your Business
At Amicus, we know how critical FDA compliance is to companies in an FDA-regulated industry. Our services are designed to identify potential compliance issues and provide robust solutions to ensure you produce quality products. With Amicus, you can avoid negative FDA action, protect your company's reputation, comply with GMP regulations, and improve your business efficiency and profitability.
While most GMP consultants stop at pointing out the flaws in your manufacturing processes, we go beyond problem identification. We work with you to understand your goals and challenges and deliver tailored solutions to help you achieve regulatory compliance. Our experienced consultants will turn obstacles into opportunities so you can succeed in a regulated industry.
GMP Consulting Services Tailored to Your Needs
At Amicus, we offer a full range of consulting services to support your business to meet and exceed federal regulations. We will guide you through every step of the compliance process to get your operations efficient, productive, and fully compliant with all regulations.
Quality Assurance
We offer a wide range of Quality Assurance solutions to help you maintain product quality and compliance.
Audits
Regular Audits are an integral part of ensuring compliance and continuous quality improvement in your products. Amicus offers GMP audits and due diligence audits to protect your potential investment.
Project Management
Amicus deploys lean and agile project management principles to assist you with large and small projects so you can deliver projects faster and better.
Temperature Mapping & Validation
We assist with protocol development and execution of temperature mapping and validation of your warehouse & product storage, incubators, SIP cycle, Autoclaves, and dry heat sterilization & depyrogenation so you can store and maintain product integrity.
Production Process Development
Amicus can assist with all aspects of GMP product development. Whether we’re doing the heavy lifting or simply providing review and advisory services, we can help your team get better results.
Facility Design & Automation
We work with your engineering design firm or cleanroom manufacturer to outline necessary facility specifications. We also assist with the selection and sourcing of automated fill-finish equipment.
Process and Equipment Validation & Qualification
Amicus provides services for almost any type of validation project. Our range of validation and qualification services allows you to prove everything is compliant with good manufacturing practice standards.
The GMP Consulting Service Plan
Initial Consultation
Assessment and Planning
Customized Solution Development
Implementation Support
Ongoing Monitoring and Improvement
Frequently Asked Questions
Amicus serves 503b outsourcing facilities, pharmaceutical manufacturing companies, cannabis product manufacturers, medical device companies, and other FDA-regulated businesses.
Amicus offers a wide range of services to get your operations FDA-compliant and ready for regulatory inspections to prevent costly penalties and negative FDA action.
Your average GMP consultant will only identify problems, while Amicus delivers solutions to your specific needs and resources. We turn challenges into opportunities and work with you to overcome them.
Yes, Amicus can support projects of all sizes to deliver fast and better.
Amicus does GMP and due diligence audits to help you achieve GMP compliance and protect your assets.
Yes. We will monitor your operations and provide support to ensure ongoing compliance and continuous improvement.
Get Started Today!
Partner with Amicus and turn your compliance challenges into opportunities for growth. Contact us now to book your consultation and see how we can help your business.
