AUSTAR Connecting Extraordinary Ideas

Consulting & Engineering Technical Services

Compliance and Validation

Digital Factory

Clean Room HVAC/EMS/BMS

Upgrade, Retrofit & Maintenance

Consulting & Engineering Technical Services

Consulting & Engineering Design

Quality Compliance & Technical Services

Integrating quality compliance and technical expertise to provide full‑cycle pharmaceutical engineering support from design to sustainable compliance.

Feasibility Study

Professional feasibility & due diligence: identify value, nitigate risks.

Plant Location and Space Evaluation

Power and Utility Work Evaluation

Project Schedule Evaluation

Project Investment Evaluation

Human Resource Evaluation

Professional site selection support: conducting feasibility studies and due diligence to identify optimal locations with superior infrastructure, maximizing returns and minimizing risks.

GMP Front End Consulting

GMP compliant engineering expertise delivers systematic early-stage design solutions.

Site Master Plan

GMP Layout Design

Flow Design

Validation Plan

Contamination Control Strategy

URS

BIM

GMP compliance anchors every project from day one: upfront integration of regulatory requirements and engineering expertise yields integrated design packages aligned with NMPA, FDA, EMA, PIC/S and WHO standards.

Engineering Design

Ensure project quality, schedule, and cost control through comprehensive and robust design.

Detailed design of process systems

Detailed design of buildings and facilities

BIM modeling, process and logistics simulation

Technical bidding documents, GMP system URS

Validation strategy and master plan

Investment analysis and quantity takeoff

Clear, complete construction drawings safeguard quality, schedule, and cost control. Our extensive project experience enables high-quality detailed design delivery.

Sustainability Consulting

Green, smart & digital solutions for pharma's low-carbon transition & lasting competitiveness.

Energy-saving evaluation & design （low-energy HVAC, intelligent pressure differential control）

Green Process Assessment & Optimization

EHS Compliance & Circular Economy

Smart Utility Systems & Auxiliary Facilities

Digitalized Production Operations

Sustainable Supply Chain & Logistics

End‑to‑end sustainable solutions from planning to digital operations for energy‑efficient, low‑carbon, and competitive pharma operations.

Design Review

Conduct GMP compliance review with SME support to meet clients needs and regulatory standards.

GMP compliance (architecture, structural, process, MEP, etc.)

Conformance with user requirements and design standards

Gap analysis and corrective recommendations

Lean manufacturing and energy efficiency

EHS (Environment, Health, Safety)

Constructability and maintainability

Materials and space management

Relying on our GMP compliance team, engineering design resources, and SME prfessionals, AUSTAR efficiently provide multi-dimensional design review services aligning with user requirements and regulatory standards.

EHS Risk Assessment

Perform full lifecycle EHS risk assessments to enhance safety, health, and environmental performance.

Reducing EHS Risks is a long-term mission. With deep understanding of biosafety, high toxicity, high potent products and process, we provide professional EHS risk assessment to help achieve a safer, healthier and more environment-friendly operating environment.

Providing end-to-end professional services including project management, engineering, procurement support, EHS and on-site execution—delivered by experienced teams ensure efficient and high-quality project delivery.

Comprehensive Validation Strategy Solutions

Full life-cycle validation support to ensure compliance, stability, and quality risk control.

End-to-end GxP validation consulting services

Specialized consulting in technology transfer, site change, cross-contamination risk assessment, contamination control, and other specific areas

Covers all types of lifecycle-based validation activities to ensure corporate compliance and operational stability while reducing quality risks.

GxP-PQS System Establishment and Optimization

Optimize quality systems for production to drive compliant Improvement.

Building a quality system that meets international regulatory requirements

Quality system gap analysis and continuous optimization

Applicable across diverse production models and product types, assisting companies in building/upgrading robust quality systems for operational excellence and compliance.

Inspection, Audit & Regulatory Submission Services

Mock audits, regulatory support & market strategies for inspections & launches.

Comprehensive Inspection and Audit Support

Personnel Training

Regulatory Dossier Preparation /Review /Submission, Amendments, and Post-Approval Maintenance

Strategic Market Planning Consultation

Mock audits, on‑site support, and market strategies to help clients pass inspections and launch compliant products efficiently.

Project Management

Professional teams help achieve project goals in quality, schedule, and cost.

Full-cycle project management and implementation guidance

GEP compliance and risk mitigation consulting

Project planning and control

Design management and technical solutions

Engineering permits and procurement management

Quality, EHS, and risk management

Change evaluation and review

CQV (Commissioning, Qualification, Validation) management

Document control, acceptance, and handover

Proven project-management systems and professional teams provide full-cycle, full-scope construction-management services for life sciences sector.

On-Site Services

On-site technical and management support: ensure compliant, efficient, and reliable project execution.

BIM technical support

Review and confirmation of detailed design drawings

Cleanroom core area construction and technical support (including project managers, MEP managers, engineers, CQV and EHS experts)

On-site inspection and audit of key GEP stages

Efficient and compliant on-site technical and management support to ensure construction quality, schedule, and regulatory compliance.

Procurement Services

Help meet quality and regulatory requirements through procurement and supply chain management.

Procurement strategy and supplier management

Preparation and review of technical specifications and URS

Engineering procurement and contract management

Support for FAT/SAT of critical equipment

Review and guidance of supplier documentation (GMP validation and operations)

Offering end-to-end procurement management and technical support to ensure equipment and materials meet quality, regulatory, and operational requirements.

Compliance and Validation

Providing clients with cutting-edge knowledge of laws and regulations, business philosophy and management approaches in the aspect of drug life cycle compliance, quality management system, qualification and validation, pharmaceutical production contamination control, laboratory design and compliance verification, lean operation and good project management, helping improve operation efficiency.

Quality Management System

Leveraging ICH Q10, empower clients to establish quality system for cost-efficiency.

Building on ICH Q10, we use risk management & scientific analysis to deliver lifecycle-compliant pharmaceutical quality systems (FDA/EMA/MHRA/NMPA/PMDA/WHO) – guiding clients from passive to proactive, cutting costs, boosting efficiency, satisfaction & profits.

Risk Control Strategy

Risk management empowers pharma lifecycle decision-making.

Risk management provides pharmaceutical enterprises essential tools for sound decision-making across the drug lifecycle, using consistent, metric-aligned workflows to trace risks, define action plans, and efficiently manage organizational knowledge.

Technology Transfer Management

Enabling seamless knowledge transfer & success.

Consultative management services cover the full lifecycle of technology transfer projects, coordinating resources across design, evaluation, risk assessment, verification, and compliance to build seamless communication and knowledge transfer bridges for project success.

Contamination Control Strategy

Enhance quality risk control & optimize resources/benefits via CCS.

CCS implementation through enhanced quality risk assessment and pharmaceutical quality systems enables control interaction, establishes contamination risk awareness, reduces inefficiency and subjectivity, and optimizes resources and continuous improvement.

Digital Factory

Offering full-lifecycle digital solutions covering strategic consulting, system implementation, and after-sales service. Delivered through deep processes, regulatory and lean expertise, digitizing warehousing, production, quality and equipment management process. Multiple implementations have earned ISPE International Engineering Awards.

Digitalization Plan & Blueprint Design

End-to-end digital factory: transparent, efficient, data-driven.

Digitized factory consultation helps define objectives, technical routes, and feasibility; analyze investment effectiveness and risks; and provide resource/outsourcing recommendations to ensure steady implementation and effective supplier management.

Value Stream Rebuilt & Lean Management

Lean transformation: enhance quality, cost efficiency, delivery, and safety performance.

Pharma LeanTec is committed to helping clients to realize excellent production operational management with a view to bring measurable and remarkable benefits in terms of quality, cost, delivery, safety, etc.

Utility System

Integrated utility automation for reliability, efficiency & performance.

Offering automation solutions of utilities including building management system (BMS), GMP critical parameters monitoring system (GMS), public circulating water system, industrial steam, air pressure system, weak current system integration and equipment system upgrade, etc. Advanced perfect controlling systems assists to reduce energy consumption, guarantee clean room environment, and reduce equipment failure and maintenance & operation cost.

Energy Conservation & Efficiency Solutions

Lean-digital optimization: cut energy use, boost efficiency.

Leveraging an integrated framework of Lean, Digitalization, and System Optimization, we deliver green, high-efficiency solutions tailored to the real-world operations of pharmaceutical enterprises:

Lean Production – Increase equipment efficiency and reduce energy consumption

System Optimization – End-to-end automation for streamlined, high-efficiency operations

Equipment Interconnection – Full-process energy management for utility systems (cooling water, purified water, WFI/distilled water)

Industrial AI – Intelligent optimization of utility and energy system performance

Process Control System

GMP-aligned process control: stable production, low variability.

Our professional teams help clients with process optimization, engineering design optimization, project implementation & management, and operation & maintenance. We model and standardize complex processes into stable, visible, and compliant automated workflows, widely applied in API, formulations, biopharmaceuticals, traditional Chinese medicine and other fields.

Lean-Based Digitalization Solutions

Lean-based digital system: full traceability, faster pharma digital transformation.

Pharma LeanDigital, a digital system brand under AUSTAR, it applies lean principles to integrate production, warehousing, and quality management, enabling regulatory-compliant full-process traceability and accelerating digital transformation. Solution Portfolio Includes:

Manufacturing Execution System (MES)

Warehouse Management System (WMS)

Material Control System (MCS)

Advanced Planning & Scheduling (APS)

Cleanroom Access Management (CAM)

Data Analysis System (DAS)

Business Intelligence Platform (BI)

Enterprise Asset Management (EAM)

Overall Equipment Effectiveness (OEE)