Solving Problems & Creating Solutions for Multiple Industries
FDA Regulated Industries We Serve
Creating Value Through Compliance
At Amicus, our comprehensive services identify problems that may threaten FDA compliance and design solutions to ensure that you manufacture quality products. We focus on your business and industry to develop solutions that aim to prevent negative FDA action and improve your business’s profitability with increased efficiency, productivity, and scale.
Services for Various Industries
We offer a variety of services for many different FDA Regulated Industries, including
503B Outsourcing Facilities
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 ensure that your facility meets FDA standards.
(Sterile & Non-Sterile)
This is an industry that has many processes for the FDA to inspect. We’ll ensure that your product is compliant on every level, from development to delivery.
Large Hospital Systems/IDNs
If you’re running a healthcare facility, you want to ensure that you provide your patients high-quality care. We can help you do this by auditing 503B providers or by assisting with your goals to develop an in-house 503B or compounding program.
Cannabis Manufacturing &
In the Cannabis industry, there are strict quality-control guidelines and ethical standards that facilities must uphold. Trust us to ensure that you’re delivering quality products.
Develop An Action Plan Right for Your Industry
If you worked with a GMP consultant in the past, they might have identified problems but offered no real solutions. Or, they could have given you an action plan that wasn’t right for your business or your industry.
At Amicus, we start 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 with a plan that works specifically for your company.