Validation and Quality Assurance Support

Ensuring compliance and quality in biotech and pharmaceutical manufacturing is critical to product success and regulatory approval. GCP provides comprehensive Validation and Quality Assurance (QA) support, helping organizations navigate stringent regulatory requirements while optimizing processes for efficiency and reliability.

Our Expertise Includes:
Process Validation (PV) & Qualification – End-to-end support for Process Validation (PV), Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
Equipment & Facility Qualification – Commissioning, Qualification, and Validation (CQV) services for manufacturing equipment, utilities, and facilities.
Computer System Validation (CSV) & Data Integrity – Ensuring GxP compliance in IT systems, including ERP, LIMS, MES, and cloud-based solutions.
Cleaning & Shipping Validation – Risk-based strategies to validate cleaning procedures and shipping conditions for global supply chain compliance.
Regulatory Readiness & Audit Support – Gap assessments, mock audits, and remediation strategies to meet FDA, EMA, and other global regulatory expectations.

Cell and Gene Therapy Support

With extensive experience in cell and gene therapy (CGT), GCP offers specialized consulting to accelerate development and ensure compliance across the product lifecycle. We understand the unique challenges of autologous, allogeneic, and viral vector-based therapies and provide tailored solutions for process robustness and regulatory success.

Our Expertise Includes:

  • Process Development & Tech Transfer – Scaling from clinical to commercial manufacturing with a strong focus on reproducibility and CMC compliance.
  • Aseptic Processing & Contamination Control – Strategies for contamination risk mitigation in high-risk CGT manufacturing environments.
  • Manufacturing & Analytical Method Validation – Ensuring product consistency and regulatory compliance for ATMPs.
  • BLA & IND Regulatory Support – Authoring and reviewing regulatory filings to streamline interactions with global health authorities.

AI STRATEGIC ADVISORY SERVICES

Artificial Intelligence (AI) is revolutionizing compliance, validation, and manufacturing processes in life sciences. At GCP, we provide AI advisory and implementation consulting to help companies adopt intelligent automation, enhance regulatory intelligence, and improve operational efficiency.

Our Expertise Includes:
AI in Regulatory & Compliance – Automating document generation, regulatory reporting, and compliance risk assessment.
AI-Driven Validation & Quality Intelligence – Leveraging AI for real-time data analysis, deviation management, and predictive quality insights.
Digital Transformation Strategy – Developing AI roadmaps tailored to compliance-heavy industries.
AI Tool Selection & Implementation – Helping organizations evaluate, integrate, and validate AI-powered solutions for GxP environments.
Training & Change Management – Supporting teams with AI adoption and regulatory compliance for machine learning applications.

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