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​GxP Biotech Compliance Services

Compliance Support for Regulated Biotech Operations

At GxP Auditing and Consulting Services, we help biotech companies navigate complex regulatory requirements through comprehensive GxP biotech compliance services. Whether you're scaling early-stage production, preparing for a regulatory inspection, or improving quality systems, our team is equipped to support your compliance goals across GMP, GCP, and GLP standards.
 

Our consultants and auditors bring decades of experience in supporting biologics, cell and gene therapies, radiopharmaceuticals, and biosimilars, ensuring your operations are aligned with FDA, EMA, MHRA, PMDA, and WHO expectations.

Why GxP Compliance Matters in Biotech

Biotech operations often involve advanced modalities and evolving technologies, but regulatory expectations remain constant: consistent, traceable, and validated processes. Non-compliance with GxP guidelines can result in 483 observations, delays in product approval, or even clinical holds.
 

Maintaining audit-ready systems and processes isn’t just about avoiding penalties; it’s about building safe, effective, and marketable products. Our GxP biotech compliance services help companies achieve operational excellence while staying aligned with global regulations.

Who We Help

We work with biotech organizations across various stages of growth, from early-stage startups to mid-size biopharma and research institutions. Our clients include teams developing:

  • Biologics and biosimilars

  • Cell and gene therapies

  • Radiopharmaceuticals and sterile injectables

  • mRNA-based therapies and vaccines

  • Investigational drugs (IND, BLA, MAA stage)
     

Whether you're preparing for first-in-human trials or commercial manufacturing, we provide the regulatory expertise and hands-on support to meet your compliance objectives.

GxP Regulatory Compliance Support

FDA, EMA, and ICH Compliance Readiness:

  • Ensure compliance with FDA (21 CFR Parts 210, 211, 820, and 11) and EMA guidelines.

  • Align company processes with ICH Q7, Q9, Q10, and E6(R2) standards.

  • Assist with compliance to global standards like PIC/S and WHO GMP.

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Regulatory Submissions Assistance:

  • Prepare and review quality sections for IND, NDA, BLA, or MAA applications.

  • Assist in responding to health authority inquiries and inspection findings (e.g., FDA Form 483 or warning letters).

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Gap Analysis & Risk-Based Assessments:

  • Perform detailed gap assessments of existing systems against regulatory requirements.

  • Develop risk mitigation strategies using ICH Q9 principles to prioritize areas for improvement.

GxP Inspection Readiness & Audit Support

Mock Audits and Inspections:

  • Simulate regulatory inspections for GMP/GCP sites, including FDA, EMA, or MHRA-style audits.

  • Assess processes for compliance risks and develop corrective action plans.

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Post-Inspection Support & CAPA:

  • Assist with inspection findings, such as FDA 483s, and create action plans to resolve compliance issues.

  • Support CAPA tracking to ensure timely resolution and effectiveness checks.

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Vendor Qualification & Oversight Audits:

  • Conduct audits of CROs, CMOs, CDMOs, and suppliers to ensure compliance with GMP and GCP.

  • Develop qualification plans for vendors and monitor their performance.

Process Validation & Qualification

Process & Equipment Validation:

  • Support the development and execution of validation protocols (IQ, OQ, PQ) to confirm that processes perform consistently.

  • Perform cleaning validation to ensure that equipment cleaning procedures remove residues to acceptable levels.

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Product Quality Review (PQR):

  • Conduct annual product reviews to assess batch consistency, stability, and process deviations.

  • Identify trends in deviations or product complaints to implement preventive measures.

Lot Release and Quality Control Support

Batch Record Review & Lot Release:

  • Review batch records for compliance with approved specifications and ensure any deviations are investigated and resolved.

  • Provide independent QA support to facilitate timely lot disposition for clinical or commercial use.

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Stability Program Management:

  • Develop stability protocols to ensure products remain within specification throughout their shelf life.

  • Monitor stability data to identify potential trends and prepare reports for regulatory submissions.

Training & Continuous Improvement Services

Customized Training Programs:

  • Develop specialized GMP/GCP training programs for employees, ensuring that everyone understands their role in maintaining compliance.

  • Provide ongoing training sessions on data integrity, CAPA management, and inspection readiness.

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Deviation and CAPA Management:

  • Implement root cause analysis tools (e.g., 5-Whys, Fishbone Diagrams) to identify the underlying causes of deviations.

  • Establish procedures to track CAPA effectiveness, preventing recurrence of issues.

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Continuous Improvement (Lean & Six Sigma):

  • Apply Lean principles to eliminate waste and improve efficiency in manufacturing and quality operations.

  • Use Six Sigma techniques to reduce variability and improve process quality, resulting in fewer deviations.

Quality Management System (QMS) Development & Optimization

QMS Design & Implementation:​

  • Build a tailored QMS aligned with ICH Q10 principles, ensuring it covers:

    • Deviation management

    • Corrective and preventive actions (CAPA)

    • Change control and document management

  • Create SOPs to standardize processes like material handling, product release, and environmental monitoring.

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Change Control and Continuous Monitoring:

  • Develop procedures to assess the risks of process changes, such as equipment upgrades or material switches.

  • Implement systems for real-time monitoring of compliance metrics (deviations, complaints, non-conformances).

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Internal Audits & Monitoring Programs:

  • Design and execute a calendar of internal audits across departments (manufacturing, QC, QA, and clinical).

  • Track audit findings and corrective actions to ensure sustained compliance and continuous improvement.

Clinical Trial Oversight & Compliance

GCP Site Audits and Monitoring:

  • Assess clinical trial sites for protocol adherence, patient safety, and GCP compliance.

  • Verify that investigators follow informed consent procedures and patient confidentiality requirements.

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Trial Master File (TMF) Audits:

  • Perform comprehensive TMF audits to confirm all essential clinical documentation is accurate and up-to-date.

  • Ensure that regulatory approvals, IRB submissions, and monitoring reports are well-documented.

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CRO and Vendor Management:

  • Develop qualification criteria for CROs, central labs, and other service providers.

  • Establish oversight programs to track vendor performance and ensure clinical trial quality.

Data Integrity & Digital Compliance

Data Integrity Audits:

  • Evaluate data management practices for compliance with FDA’s 21 CFR Part 11 and EU Annex 11.

  • Identify gaps in electronic data management, including incomplete audit trails, improper access controls, and missing signatures.

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Digital System Validation (CSV):

  • Validate software systems used in the manufacturing and clinical processes (e.g., LIMS, ERP, SCADA).

  • Develop protocols to confirm that systems consistently capture accurate data and generate complete audit trails.

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Data Governance & Integrity Remediation Plans:

  • Create data integrity governance frameworks to ensure ALCOA+ principles are followed (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).

  • Implement corrective actions for identified issues, including staff training and system reconfigurations.

External Manufacturing & Quality Oversight

CMO/CDMO Oversight:

  • Monitor external manufacturing partners to ensure they meet regulatory and quality expectations.

  • Conduct regular audits and provide on-site quality oversight during critical production stages.

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Supplier Qualification & Management:

  • Develop supplier qualification programs to assess vendors’ capabilities and ensure they meet quality standards.

  • Monitor supplier performance through metrics like on-time delivery, deviation reports, and customer complaints.

  • Implement ongoing monitoring through regular audits, performance scorecards, and clear communication channels to maintain quality standards.

What Sets Our Biotech Compliance Services Apart

  1. Specialized GxP Focus: Our team doesn't generalize; we specialize in biotech-specific GxP auditing and compliance support.
     

  2. Inspection-Ready Documentation: Every system, process, and SOP we help implement is built to withstand FDA or EMA scrutiny.
     

  3. Cross-Functional Experience: We understand the interplay between quality, clinical, digital systems, and manufacturing.
     

  4. Confidential & Trusted: We work closely with your internal team, ensuring privacy, transparency, and actionable recommendations.

Frequently Asked Questions (FAQs)

Let’s Get Your Biotech Operation Audit-Ready

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