Ensure FDA Compliance
with Amicus

Discover Our Proven Track Record For Success

Creating Value Through Compliance

At Amicus, our comprehensive services identify problems that may threaten FDA compliance and create solutions to ensure that you manufacture quality products. Our solutions prevent negative FDA action and improve your business’s profitability with increased efficiency, productivity, and scale.

Business analyst team checking on financial statement for business valuation and audit.

Our Services

We provide solutions that stand up to FDA scrutiny.

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.

We Collaborate With You to Identify Problems And Solve Them

Most other consultants provide a list of problems but no real solutions. At Amicus, we help you succeed by understanding 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 see problems as opportunities. Whatever obstacles you face when it comes to ensuring FDA compliance, we’ll work with you to develop a solution. The word “No” is not a part of our vocabulary.

Let’s Start Coming Up with Solutions

We want to see your business succeed. Call us today so we can point you in the right direction.