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Quality Oversight for Clinical Sponsors

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.

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.

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

Supporting Every Phase of Clinical Development

Phase I

Early Development

Foundational quality systems and CDMO qualification for first-in-human studies

Phase II

Expanded Studies

Enhanced quality oversight and scale-up support as programs expand

Phase III

Pivotal Trials

Comprehensive quality systems preparing for commercial manufacturing

Launch

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

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.

The validation support from Amicus was excellent. Their team brought real-world CQV experience that helped us commission our new facility on schedule while staying aligned with our validation master plan and regulatory expectations.

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.

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.

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.

Working with Amicus on a mock FDA audit was a great experience. Their team was thorough, professional, and easy to work with, and they provided clear feedback that helped us better understand regulatory expectations.

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.

Book a Consultation