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ICON Stronger Compliance & Risk Management 300X300

Stronger Compliance & Risk Management

ICON Improved Product & Process Quality 300X300

Improved Product & Process Quality

ICON Stronger Audit & Certification Readiness 300X300

Stronger Audit & Certification Readiness

Quality & Regulatory Compliance

At Total Plant Setup, we deliver comprehensive Quality & Regulatory Compliance Solutions that enable businesses to meet rigorous industry standards and safeguard brand reputation. Our services begin with Industry-Specific Regulatory Compliance Consulting, tailored to manufacturing, automotive, medical devices, pharmaceuticals, aerospace, and more. We conduct thorough Internal & External Compliance Audits, bridging gaps before third-party evaluations. Our Regulatory Reporting & Digital Compliance Management systems ensure real-time adherence to ISO, FDA, GMP, CE, IEC, AS9100, RoHS, REACH, and beyond. Product Compliance & Certification Management covers end-to-end approvals, labeling, and global documentation. We also offer Regulatory Compliance Programs, Process Validation & Continuous Improvement to maintain certifications.

  • Industry-Specific Regulatory Compliance
  • Internal & External Compliance Audits
  • Regulatory Reporting & Digital Compliance
  • Product Compliance & Certification
  • Regulatory Training & Workforce Programs
  • Process Validation & Continuous Improvement
Border Sub Serv 1500 x 150 px

Quality & Regulatory Compliance: Key Offerings

We provide tailored compliance consulting, audits, certification support, digital reporting, and workforce training—ensuring adherence to global standards like ISO, FDA, and CE for improved product quality, and continuous compliance in regulated industries.

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  • Develop Tailored Compliance Frameworks: Align strategies with industry-specific regulations like ISO, FDA, GMP, and CE for global market access.
  • Ensure Regulatory Readiness: Conduct gap assessments and compliance audits to mitigate risks and improve operational transparency.
  • Streamline Certification Processes: Guide businesses through regulatory approvals, ensuring adherence to legal and environmental compliance standards.
  • Conduct Pre-Certification Assessments: Identify regulatory gaps through internal audits to prepare for third-party certification and compliance checks.
  • Perform Supplier Compliance Audits: Evaluate vendor adherence to industry regulations, ensuring supply chain accountability and risk mitigation.
  • Enhance Regulatory Adherence: Implement corrective action plans based on audit findings to improve compliance and operational efficiency.
  • Automate Compliance Tracking: Implement digital systems for real-time monitoring and documentation of regulatory requirements.
  • Ensure Accurate Reporting: Develop custom dashboards and audit logs to simplify regulatory filings and reporting obligations.
  • Improve Document Control: Utilize electronic document management systems (EDMS) to ensure compliance with industry and government standards.
  • Manage Global Certification Requirements: Oversee regulatory approvals, documentation, and labeling for product compliance in international markets.
  • Ensure Environmental Compliance: Adhere to sustainability regulations like RoHS, REACH, and WEEE for eco-friendly product certifications.
  • Facilitate Testing & Validation: Coordinate with accredited labs for product safety and quality testing, ensuring regulatory conformity.
  • Deliver Industry-Specific Training: Educate employees on compliance policies, quality management, and regulatory changes to maintain operational integrity.
  • Strengthen Ethical Governance: Implement workplace training on safety standards, legal regulations, and corporate compliance best practices.
  • Develop Compliance Handbooks: Create SOPs, regulatory guidelines, and customized manuals for ongoing workforce compliance training.
  • Establish Process Validation Protocols: Implement regulatory-driven validation strategies to maintain quality consistency in manufacturing.
  • Ensure Continuous Compliance Monitoring: Conduct periodic assessments and audits to sustain long-term adherence to industry regulations.
  • Optimize Regulatory Readiness: Implement process improvements and digital solutions for ongoing compliance with FDA, GMP, and ISO standards.
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Smart Industry Solutions for Modern Manufacturing

Industrial Automation & Robotics

Accelerating Smart Automation with AI, machine learning, edge computing, and digital twins to boost manufacturing efficiency.

Manufacturing Facility Setup

Building efficient factories via location planning, engineering layouts, automation, regulatory compliance, and streamlined supply chains.

Enterprise Resource Planning

Empowering business efficiency with ERP & CRM using SAP S/4HANA, Oracle Cloud, Dynamics 365, NetSuite & Odoo.

Supply Chain & Inventory Optimization

Revolutionizing supply chains with demand forecasting, predictive analytics, and digital twins for agility, resilience, and cost-efficiency.

Business Process Automation

Delivering BPA through MES, AI analytics, IoT-driven automation, and RPA to streamline intelligent manufacturing.

Quality & Regulatory Compliance

Strengthening businesses with quality systems, compliance consulting, regulatory audits, certifications, and industry-specific compliance solutions.

One Step Ahead in Building Smart Factories

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Streamline your manufacturing with our strategic integration of robotics, automation,  ERP, & supply chain solutions – building a smart factory that enables operational excellence.

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  • Bangalore, India

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