Regulatory Compliance Consulting
Risk-based compliance strategy, gap assessments and documentation support for teams operating under FDA scrutiny.
Request a consultation
Talk through where your compliance gaps sit.
89 clients supported across 8 industries. 125+ years of combined GMP experience.
The first call is discovery, no confidential details needed. We sign a CDA before any detailed review.
Regulatory Compliance Consulting for Regulated Life Science Companies
Regulatory compliance is not a document you produce once. It is a set of systems that have to hold up when someone external examines them, at whatever stage your product happens to be in. What is adequate for a Phase I program will not survive a pre-approval inspection, and what worked at one site rarely transfers cleanly to a second.
Amicus helps pharmaceutical, biotech and 503B teams build compliance that fits where they actually are. We assess your current position against current FDA expectations, identify the gaps that carry real regulatory risk, and work alongside your team to close them. A principal scopes the engagement and stays accountable for it through implementation.
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 & RegulatoryOur Regulatory Compliance Consulting Services
5 areas of support
GMP Compliance Strategy
We develop risk-based compliance strategies tailored to your product phase, aligned with current FDA expectations and applicable international standards. The strategy accounts for what you can resource, not only what an ideal quality system would look like.
Quality System Assessment and Improvement
A thorough evaluation of your existing quality management system to identify gaps and implement practical improvements that strengthen compliance without adding process for its own sake. We look at what your system does, not only what its procedures say it does.
Regulatory Gap Assessments
Detailed assessments against 21 CFR Parts 210 and 211 and other applicable regulations, to identify and address compliance vulnerabilities before a regulator does. Findings come back ranked by risk with a remediation sequence attached.
SOP and Documentation Support
We draft, review and optimize standard operating procedures and critical quality documentation for clarity, compliance and ease of execution. A procedure people cannot follow under pressure is a finding waiting to happen.
Inspection Readiness Planning
We prepare your team for FDA inspections through mock audits, front room and back room training, and comprehensive readiness planning, so the compliance work you have done can actually be demonstrated.
Common Regulatory Compliance Challenges We Help Solve
Evolving FDA Expectations
Guidance shifts, enforcement priorities move, and what passed an inspection three years ago may not pass the next one. We keep your compliance position current rather than frozen at the date of your last assessment.
Inconsistent Quality Systems
Systems that developed piecemeal as the company grew, differ between sites, or exist on paper but are worked around in practice. These are the gaps that produce repeat observations.
Documentation and Training Gaps
Procedures that do not match practice, training records that cannot demonstrate competence, and documentation that tells an incomplete story to anyone reading it cold.
Readiness for Audits and Inspections
Being compliant and being able to prove it under questioning are two different capabilities. We build both.
Why Companies Choose Amicus for Regulatory Compliance Consulting
A named Amicus principal leads every engagement. The principal scopes the work, defines the plan, and reviews and confirms every recommendation before it reaches you; senior consultants may carry out the assessment and documentation work to that plan. With 125+ years of combined experience across 89 clients and 8 industries, we tailor every engagement to your stage, scale and regulatory history, and we stay through implementation rather than handing over a report.
What Our Clients Say
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
Amicus provided hands-on support as we scaled our manufacturing operations. Their consultants worked closely with our team to improve documentation, refine procedures, and ensure our systems aligned with cGMP expectations.
Head of ManufacturingBiotech Company
Frequently Asked Questions
With a gap assessment. It is difficult to build a sensible compliance strategy without an accurate picture of the current position, and most teams are surprised by at least one finding.
That is the normal arrangement. We work alongside internal quality teams, adding capacity and outside perspective rather than taking over.
Yes. Building the system before the first inspection is considerably easier than remediating after one.
An audit tells you where the gaps are at a point in time. Compliance consulting is the work of closing them and keeping the system current afterwards.
Yes. The first call is a discovery conversation and no confidential details are needed for it. We sign a CDA before any detailed review.
Related Compliance and Audit Services
FDA Inspection Readiness Consulting
Mock inspections, gap assessments and live inspection support.
FDA 483 & Warning Letter Response
Risk-ranked remediation when observations have already been issued.
503B Outsourcing Facility Compliance
GMP and inspection support for registered outsourcing facilities.
Speak With a Regulatory Compliance Consultant
Tell us where you are in your product lifecycle and what is worrying you. We will tell you what we would look at first.