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Empowering pharmaceutical and biotechnology manufacturers to achieve international quality standards with cutting-edge compliance, automation, and consultancy services.
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PBS Engineers have been working on all aspects of Pharma and Biotechnology manufacturing production, including validation, Quality Management Systems (QMS), Manufacturing Execution Systems (MES), Automation Solutions, GMP Consultancy, and Training.
We are committed to delivering international best practices and advanced technological solutions to help our clients in China meet global regulatory standards set by the FDA, EU, NMPA, and MHRA.
We offer a full suite of services designed to streamline compliance, enhance manufacturing efficiency, and ensure product quality across the pharmaceutical and biotechnology sectors.
Implement robust, compliant QMS platforms powered by MasterControl to manage documents, deviations, CAPA, audits, and change control with full traceability and automation.
Integrate advanced automation systems to reduce human error, increase process consistency, and improve data integrity across manufacturing and laboratory environments.
Expert guidance on Good Manufacturing Practices (GMP) compliance, including facility design, process validation, quality systems, and regulatory submissions.
Real-time monitoring and control of production processes with MES to ensure batch accuracy, traceability, and compliance with 21 CFR Part 11.
Comprehensive validation of equipment, facilities, processes, and computerized systems to ensure compliance with global regulatory requirements.
Customized training programs for personnel on GMP, quality systems, automation, and regulatory compliance to build internal capability.
As a trusted partner, we implement MasterControl's industry-leading quality and compliance software to help clients accelerate time-to-market and reduce compliance costs.
Specialized support for Original Equipment Manufacturers in the pharma sector, ensuring equipment design, documentation, and integration meet regulatory standards.
1993
Founded
30+
Years of Experience
500+
Global Clients
100%
Compliance Focus
Stay ahead with our expert analysis on the latest regulatory changes impacting biopharmaceutical manufacturers in China.
Join our upcoming workshop on Good Manufacturing Practices for pharmaceutical professionals in Shanghai this October.
We’re excited to announce the successful deployment of MasterControl’s cloud-based QMS for three major clients in Q3 2025.
We primarily serve pharmaceutical and biotechnology companies in China, with expertise in aligning operations to international standards (FDA, EU, MHRA, NMPA).
Yes, we provide both on-site and remote consultancy, training, and system implementation services depending on client needs.
Yes, MasterControl is fully compliant with 21 CFR Part 11, Annex 11, and other global electronic record and signature regulations.
Absolutely. Our team offers mock audits, gap assessments, documentation reviews, and training to prepare clients for FDA and other regulatory inspections.
For inquiries about our solutions, partnerships, or services, please visit our official website to contact us directly.
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