Ensure FDA Compliance
Helping Organizations Like Yours Succeed
Identifying Problems & Creating Solutions
If your business violates FDA regulations, you’re at risk of facing serious consequences. If you’ve worked with a consultant in the past to assess these concerns, they may have provided a list of problems but no real solutions.
At Amicus, we not only identify problems — we create solutions.
We offer a variety of services to ensure FDA approval, including:
Amicus offers QA services which range from document & systems development to staff augmentation & advisory services. In addition, Amicus assists with QA-related remediation.
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.
Amicus deploys lean and agile project management principles to assist you with large and small projects.
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 succeed.
Amicus’ team is here to fill the gaps and provide support where you need it most with facility registration, licensing, and permitting services.
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.
Amicus provides services for almost any type of validation project. From process validation design to validation of equipment & facilities, we have the experience to manage your project.
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.
The Amicus Difference
At Amicus, we help you strategize by understanding where you want to go as a business, your goals, and your available resources. Then, we determine how we can build a customized solution specifically for you to achieve your goals no matter the potential constraints.
Let Us Help You Every Step of The Way
Contact us to see how we can help you succeed and achieve your goals.