Contact us for a 30-minute discovery call. The first call is discovery, no confidential details needed. We sign a CDA before any detailed review.
We act as an extension of your team with deep regulatory, manufacturing, and quality expertise tailored to real-world operations. Our focus is on audit readiness, patient safety, and product quality, delivering practical solutions that scale with your organization.
Amicus will work with you to identify problems and develop solutions that comply with GMP requirements. If you want to avoid FDA scrutiny and improve your business’s profitability, please get in touch and our team will be happy to talk with you about the next best steps for your facility.
1122 Lady St, 3rd Floor
Columbia, SC 29201
USA
We reply from Columbia, SC, usually the same business day.
The first call is discovery, no confidential details needed. We sign a CDA before any detailed review.
Real partnerships delivering sustainable solutions across pharmaceutical and biotech development.
Amicus stepped in during a challenging FDA 483 remediation and worked right alongside our team. Their practical approach and deep knowledge of quality systems helped us resolve observations and strengthen our processes for the long term.
VP Quality AssurancePharmaceutical Manufacturer
Our mock FDA audit with Amicus was incredibly helpful. They clearly explained where we had gaps, prioritized the issues, and offered practical ideas for fixing them. It gave our team much more confidence going into future inspections.
Director of Quality503B Outsourcing Facility
Amicus was a great partner when we needed guidance responding to regulatory correspondence. Their team understood how the FDA would likely view the issues and helped us develop a clear, thoughtful response.
Director of Regulatory AffairsPharmaceutical Company