GMP Support for Pharma, Biotech and 503B
We work with pharmaceutical manufacturers, 503B outsourcing facilities, CDMOs and clinical-stage sponsors. Every engagement is led by a principal who owns the plan.
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Tell us where your organization is today.
The first call is discovery, no confidential details needed. We sign a CDA before any detailed review.
Who We Work With
Pharmaceutical Manufacturing
Quality systems, GMP audits, FDA inspection readiness and 483 remediation for sterile and non-sterile manufacturers, whether you make APIs, biologics or finished dosage forms.
503B Outsourcing Facilities
Pharmaceutical-grade compliance expectations, often without a pharmaceutical-sized team behind them. We build quality systems, batch record practices and inspection readiness that fit the facility you actually run.
CDMOs
Facility commissioning, equipment qualification and process validation, plus the quality systems and audit readiness that sponsors and the FDA expect from a contract manufacturer.
Biotech and Clinical-Stage Sponsors
Phase-appropriate sponsor quality from first-in-human studies through commercialization, including CDMO qualification and oversight, quality agreements and batch release.
One Accountable Team Across the Product Lifecycle
Amicus was built to change the consulting experience for FDA-regulated businesses. Many consultants can identify problems; few stay to solve them. A principal defines the plan for every engagement and stays accountable for the result, while our team works alongside yours to implement lasting change rather than hand over a report.
Our leadership brings over 125 years of combined regulatory, manufacturing and quality experience, so the support you get is built for the way your operation actually runs, from development and validation through commercial manufacturing.
Related Services
GMP Consulting
Hands-on support to assess findings, strengthen quality systems and prepare for FDA inspections.
CQV & Validation Services
Commissioning, qualification and validation for facilities, equipment, processes and computerized systems.
Speak With a GMP Compliance Consultant
Whether you are preparing for an FDA inspection, qualifying a new facility or building quality systems for a clinical program, Amicus can help. The first call is discovery, no confidential details needed.