CGMP

CGMP - The Core of Safe, Effective Products

CGMP is essential to the safety and effectiveness of medications and other regulated products. It builds quality into every step—from facilities and equipment to trained personnel and reproducible procedures—so each product is as safe and effective as intended. 

With more than 20 years of experience and experts from CGMP and regulatory backgrounds, Eagle Analytical delivers comprehensive, tailored services that support both Quality Assurance (QA) and Quality Control (QC). We help partners design, implement, and maintain CGMP programs that align with FDA, ICH, and other applicable regulatory standards. 

Industries We Support

We partner with organizations across the life sciences and regulated product ecosystem, including:

  • Pharmaceutical manufacturing, including CDMO/CMO/CRO operations
  • Medical device manufacturers
  • API manufacturers
  • Biologics manufacturers
  • Food and beverage producers
  • Dietary supplement manufacturers
  • Cosmetics and personal care product manufacturers

Eagle is Your CGMP Quality and Compliance Partner

When you work with Eagle Analytical, you gain access to:

  • Experts with deep CGMP and regulatory backgrounds
  • More than two decades of experience supporting regulated industries
  • Comprehensive services spanning facility, equipment, processes, documentation, and laboratory testing
  • Tailored guidance aligned with your products, risk profile, and regulatory requirements
  • We focus on practical, implementable solutions that strengthen your CGMP program and support long‑term quality and compliance.

    Services We Provide

    Eagle Analytical provides the technical, regulatory, and laboratory support needed to help you build and sustain a compliant, science-driven CGMP framework. Whether you are an established manufacturer or scaling a new operation, our team helps align your programs with current CGMP expectations.

  • Building and facilities: facility design, cleanroom design, certification
  • Equipment: calibration, qualification 
  • Production and process control: process validation, cleaning validation, disinfectant efficacy studies
  • Records and report: compliance and regulatory consulting services, CGMP quality system development, SOP development and implementation 
  • R&D: Method development, method validation, method verification, method transfer
  • Stability studies
  • Laboratory services:
    • APIs/Raw material testing 
    • Finished product and stability sample testing
    • Elemental impurities
    • Residual solvent analysis
    • Nitrosamine impurities
    • Peptide mapping