GMP Consulting Services
Facing an FDA inspection or responding to FDA 483 observations? Amicus helps pharmaceutical, biotech, and 503B teams assess findings, prioritize remediation, strengthen quality systems, and prepare for FDA inspections with hands-on GMP consulting support.
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Talk to a GMP consultant this week. Get a rapid 483 response review.
Led byJamie Duncan, CQA, Principal, Quality
The first call is discovery, no confidential details needed. We sign a CDA before any detailed review.
GMP Consulting Services Tailored to Your Needs
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 reduce the risk of 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.
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.
Jamie Duncan, CQAPrincipal, QualityJamie brings nearly a decade of experience in pharmaceutical quality, compliance and operations within highly regulated environments. She holds ASQ Certified Quality Auditor and Certified Manager of Quality/Organizational Excellence certifications, plus a Lean Six Sigma Green Belt.
- Quality system development and optimization
- Internal audits and compliance readiness
- Process improvement and operational excellence
Becca Mitchell, PharmDPrincipal, Quality & RegulatoryWhere do you need help first?
Five focused consulting services, each with its own page.
FDA 483 & Warning Letter Response
Risk-ranked remediation when observations have already been issued.
Regulatory Compliance Consulting
Strategy, gap assessments and documentation support across FDA requirements.
503B Outsourcing Facilities
GMP and inspection support for registered outsourcing facilities.
What We Do
Quality Assurance
We offer a wide range of Quality Assurance solutions to help you maintain product quality and compliance.
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.
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.
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.
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.
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.
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.
Our Consulting Process
Initial Consultation
We start with a full consultation to understand your needs, challenges, and goals.
Assessment and Planning
Our consultants conduct a full assessment to identify compliance issues and areas for improvement.
Customized Solution Development
Based on our findings, we develop solutions that utilize your existing resources to address your specific challenges.
Implementation Support
We work alongside your team to implement these solutions, providing hands-on support and expertise every step of the way.
Ongoing Monitoring and Improvement
We don’t stop after implementation. We will continue to monitor your operations to ensure ongoing compliance and continuous improvement.
Amicus in the Field
Trusted Partners in Quality & Compliance
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
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
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
Frequently Asked Questions
Amicus serves pharmaceutical manufacturers (sterile and non-sterile), 503B outsourcing facilities, CDMOs, and biotech and clinical-stage sponsors. See the industries we serve.
Amicus offers a wide range of services to get your operations FDA-compliant and ready for regulatory inspections and reduce the risk of 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.
Related Services
CQV & Validation Services
Commissioning, qualification and validation for facilities, equipment, processes and computerized systems.
Clinical Development Quality
Phase-appropriate sponsor quality oversight from IND through commercialization.
503B Outsourcing Facility Compliance
GMP and inspection support for registered outsourcing facilities.
Ready To Partner for Lasting Quality Solutions?
Let’s discuss how Amicus can support your organization’s compliance, validation, and quality objectives. Whether you’re launching a new facility, remediating FDA findings, or building quality systems, we’re here to help.