Clinical Development Quality & GMP Support
Phase-appropriate quality support from IND to BLA. We provide Quality oversight to Sponsors for early-phase clinical development through commercialization, ensuring compliance with GMP and GCP requirements.
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Led byBecca Mitchell, PharmD, Principal, Quality & Regulatory
The first call is discovery, no confidential details needed. We sign a CDA before any detailed review.
Quality Oversight for Clinical Sponsors
We meet Sponsors where they are, helping successfully get IMP to clinical sites. Our team acts as an extension of yours to deliver practical, collaborative solutions for every stage of clinical development.
How we support clinical sponsors at a glance
Becca Mitchell, PharmDPrincipal, Quality & RegulatoryBecca served six years on the Arkansas State Board of Pharmacy, including a term as Board President, alongside a decade in executive leadership at an FDA-registered sterile and non-sterile manufacturing facility. She has first-chaired dozens of FDA, DEA, state board and accreditation inspections.
- GMP quality systems and regulatory strategy
- Inspection readiness and audit leadership
- Clinical and commercial compliance support
Jamie Duncan, CQAPrincipal, QualitySupporting Every Phase of Clinical Development
Early Development
Foundational quality systems and CDMO qualification for first-in-human studies
Expanded Studies
Enhanced quality oversight and scale-up support as programs expand
Pivotal Trials
Comprehensive quality systems preparing for commercial manufacturing
Commercialization
Transition support and ongoing quality oversight post-approval
How We Support Clinical Sponsors
A collaborative, phase-appropriate approach that meets sponsors where they are and scales with development progress.
Initial Assessment
We begin by understanding your development program, phase, timelines, and existing quality infrastructure. This allows us to design a fit-for-purpose quality support model.
- Review development stage and timeline
- Assess existing quality systems
- Identify regulatory pathways and requirements
- Define scope of quality support needed
System Development
We develop phase-appropriate sponsor quality systems that are practical, compliant, and scalable as your program advances through clinical development.
- Draft sponsor SOPs and procedures
- Establish product specifications
- Develop Quality Agreements with CDMOs
- Create release and stability protocols
CDMO Qualification
Thorough qualification and ongoing oversight of contract manufacturing partners to ensure they meet quality standards and regulatory requirements.
- Conduct qualification audits (GMP/GCP)
- Negotiate and finalize Quality Agreements
- Review manufacturing documentation
- Assess capability for your product
Ongoing Oversight
Continuous quality oversight including batch review, release authorization, deviation management, and regulatory support throughout development.
- Review and approve batch records
- Authorize IMP release (CoA/CoR)
- Manage deviations and CAPAs
- Oversee stability programs
Regulatory Support
Quality review and support for IND/ANDA submissions, amendments, and ongoing regulatory compliance throughout the development lifecycle.
- Review CMC sections of submissions
- Support IND/ANDA preparation
- Quality review of clinical documents
- Interface with health authorities as needed
Commercial Transition
Support the transition from clinical to commercial manufacturing, including tech transfer, scale-up, and establishment of commercial quality systems.
- Tech transfer quality oversight
- Commercial manufacturing readiness
- BLA/NDA CMC support
- Post-approval quality systems
Why Work with Amicus?
Experienced, hands-on partners offering practical quality support that scales as development progresses
Acting as an extension of your team to fulfill regulatory oversight obligations
Authorize QA release of clinical trial material
Deep, solutions-focused expertise committed to product quality, GCP, and data integrity
Amicus in the Field
Trusted Partners in Quality & Compliance
Real partnerships delivering sustainable solutions across pharmaceutical and biotech development.
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
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
Frequently Asked Questions
Phase-appropriate support: foundational quality systems and CDMO qualification for first-in-human studies, then more oversight as the program moves toward pivotal trials and commercialization. We size the support to your phase, not to a commercial template.
Yes. We act as an extension of your team to meet sponsor oversight obligations, from drafting SOPs and quality agreements to reviewing batch records and managing deviations and CAPAs.
Yes. We review and approve batch records and authorize IMP release (CoA/CoR) as part of ongoing quality oversight. We also work closely with QPs for IMP release to ex-US sites.
Yes. We conduct GMP qualification audits, negotiate and finalize quality agreements, review manufacturing documentation, and assess whether the CDMO can consistently perform to deliver quality product for your program.
We provide quality review of CMC sections and clinical documents, support IND/ANDA preparation, and support BLA/NDA CMC sections as programs approach approval.
We support tech transfer, scale-up and commercial manufacturing readiness, and help establish the post-approval quality systems a commercial product needs.
Related Services
Regulatory Compliance Consulting
Strategy, gap assessments and documentation support across FDA requirements.
CQV & Validation Services
Commissioning, qualification and validation for facilities, equipment, processes and computerized systems.
GMP Consulting
Hands-on support to assess findings, strengthen quality systems and prepare for FDA inspections.
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.