QA/QC & ᴄGMP
Compliance

QA/QC & ᴄGMP Compliance with CMC Pharma

Maintaining quality and compliance is essential to successful drug development and commercialization. From laboratory studies to prototype preparation and large-scale manufacturing, adherence to current Good Manufacturing Practices (cGMP) and rigorous Quality Assurance (QA) and Quality Control (QC) systems is non-negotiable.

At CMC Pharma, QA/QC and cGMP compliance are fully integrated into every stage of our development and manufacturing services, including CMO selection, qualification, and ongoing oversight. Our team ensures that whether production is conducted in-house or at a partner facility, the same high standards of quality, regulatory alignment, and operational excellence are applied.

Unlike traditional labs or consultants that provide isolated QA services, CMC Pharma delivers end-to-end quality oversight, linking scientific execution, regulatory strategy, and both internal and outsourced manufacturing compliance into one seamless process.

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Why QA/QC & ᴄGMP Compliance Matters

  • Ensure Product Safety and Efficacy: Comprehensive QA/QC ensures every batch, from early prototypes to commercial production, meets specifications.
  • Regulatory Confidence: Well-documented, cGMP-compliant processes—including outsourced manufacturing—are critical to IND, NDA, and global submissions.
  • De-Risk Development: Integrated oversight identifies potential deviations, process gaps, or supplier risks early, preventing costly rework or delays.
  • Optimize Program Efficiency: Combining QA/QC with development, manufacturing enablement, and CMO oversight reduces redundant efforts and external consultancy costs.
Areas of Expertise

Our QA/QC & CMO Oversight Services

CMC Pharma provides a comprehensive quality and compliance framework that spans both internal operations and outsourced manufacturing:

CMO Selection & Qualification

Evaluate potential CMOs for compliance, technical capabilities, and regulatory readiness.
01

Ongoing CMO Oversight

Continuous monitoring of manufacturing performance, process deviations, and adherence to cGMP standards.
02

Quality Control Testing

Analytical, stability, and release testing performed under compliant procedures to ensure consistent product quality.
03

ᴄGMP Program Design & Oversight

Establish systems and SOPs that cover both in-house and outsourced manufacturing operations.
04

Audit & Risk Management

Identify gaps, manage risks, and maintain readiness for internal or regulatory audits.
05

Documentation & Record-Keeping

Comprehensive tracking of batch records, deviations, investigations, and CAPA systems across all sites.
06
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The CMC Pharma Advantage: Integrated Quality Across Internal and CMO Manufacturing

Many organizations treat outsourced manufacturing as a separate entity and rely on consultants or the CMO’s guidance to ensure quality assurance oversight. CMC Pharma integrates quality oversight directly with CMO selection, qualification, and ongoing management, ensuring:
  • Regulatory expectations are embedded in every study, prototype, and batch, no matter where it is produced.
  • Data generated in our labs or at partner sites is ready to support submissions.
  • Deviations or risks are identified and mitigated proactively.
  • Programs stay on schedule with fewer hand-offs, miscommunications, or unexpected costs.

By linking internal development and lab services with CMO selection, qualification, and oversight, CMC Pharma delivers a single, end-to-end compliance framework that reduces risk, accelerates timelines, and maximizes regulatory confidence.

Discover Our Integrated Model

Accelerating Quality & Compliance Across Programs

With CMC Pharma, QA/QC and cGMP compliance are not isolated activities—they are woven into the full development and manufacturing lifecycle, from lab studies to prototypes, scale-up, and outsourced production. This integrated model ensures:
  • Submission-ready, compliant data packages.
  • Minimized regulatory risk across all manufacturing sites.
  • Predictable timelines and optimized cost efficiency.
  • Seamless coordination between internal teams and CMOs.
Speak With Our Team

explore our Integrated Regulatory Support Services

IND/NDA Prep & Review
CMC Strategy & Execution
Agency Response Strategy

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    Partner with CMC Pharma

    Achieving regulatory compliance and high-quality drug development requires more than periodic inspections or standalone QA services. With CMC Pharma, QA/QC and CMO oversight are embedded into every aspect of your program, ensuring science, operations, and regulatory strategy work together to deliver compliant, reliable, and submission-ready outcomes.

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    Contact Us Today and find out how CMC Pharma can help you!

    CMC Pharma produces timely results to speed along your drug program for the ultimate goal of product approval.

    Send us a message or give us a call at 440-485-1734