11 Best Regulatory Compliance Software Solutions in 2025

Did you know that the regulatory compliance market is expected to grow from $21.16 billion in 2024 to $23.18 billion in 2025, reflecting a compound annual growth rate (CAGR) of 9.5%?

As a product manufacturer, managing regulatory compliance requires the right software solution, which is key to ensuring regulatory adherence, minimizing risks, and maintaining smooth operations.

With numerous regulatory compliance tools available, selecting the best option for your business can be daunting.

To make it easier, we’ve put together a list of the top 11 regulatory compliance software solutions for product manufacturers, helping you find the right fit for your needs.

Let’s dive in!

11 Regulatory Compliance Software Solutions for Product Manufacturers: Top Options to Choose From

1. Signify

Signify is a manufacturing compliance management platform that streamlines regulatory tracking, risk assessments, and evidence validation.

Our system, which leverages AI technology, simplifies conformity assessments, documentation analysis, and labeling checks, reducing compliance challenges while enhancing accuracy.

With real-time monitoring and structured workflows, Signify transforms complex regulations into clear, actionable steps, ensuring businesses remain aligned with evolving industry standards.

Whether you're a Regulatory Affairs Manager, Compliance Manager, or Quality Assurance Lead in industries like food & beverage, pharmaceuticals, cosmetics, or product safety, Signify makes regulatory processes more efficient and transparent.

Key Features

• Automated Conformity Assessments: With our AI-powered system, policies, procedures, and documentation are reviewed automatically, allowing you to identify compliance gaps in minutes rather than weeks quickly.

• Compliance Smart Checklists: Transform complex regulations into simple, actionable checklists that help you track compliance, identify gaps, and maintain alignment with industry standards.

• Global Compliance Management: Our platform simplifies multi-market regulations, allowing you to ensure your products meet diverse global standards without duplicating efforts.

• Regulatory Risk Tracker: Identify and prioritize the most critical compliance risks with intelligent tracking.

• Document Traceability: By building detailed traceability matrices, you can link regulatory requirements directly to supporting evidence within your documentation, making audits easier.

• Automated Labeling Compliance: Quickly validate your product labels against regulatory requirements, reducing revision cycles and ensuring every product is fully compliant before it goes to market.

• Proactive Regulatory Intelligence: Stay ahead of regulatory changes with continuous scanning for new updates, transforming complex data into actionable insights so you can adapt your compliance strategy early.

• Third-Party Certification Streamlining: Our platform easily prepares you for regulatory inspections and third-party certifications, automating compliance assessments and generating audit-ready documentation in minutes.

• Defensible Audit Trails: Each compliance action is thoroughly documented, ensuring full traceability and providing a comprehensive, defensible record that meets regulatory and internal governance requirements.

• Compliance Strategy Adaptation: As new regulations emerge, you can proactively adjust your compliance strategy to meet changing requirements, giving your business the flexibility to stay competitive.

• Accelerated Market Entry: Our platform helps you quickly adapt your existing compliance documentation to meet the requirements of new markets, reducing the time spent on approvals and speeding up product entry.

2. FoodReady

FoodReady offers an AI-powered, all-in-one platform that combines food traceability, production, quality, and safety software.

It helps food manufacturers comply with regulations like FDA, USDA, and GFSI certifications, while also providing expert food safety consulting.

Key Features

• HACCP/PCP Plan Builder: A drag-and-drop process flow designer with pre-built templates and a hazard database, ensuring compliance with HACCP and PCP requirements for FDA and USDA regulations.

• Automated Supplier Document Management: Automates the collection and storage of supplier documentation to simplify verification and ensure supply chain compliance.

• Traceability & Recall Management: Connects shipping and receiving logs to sales and purchase orders for efficient product tracking and recall management, in line with FSMA 204.

• Operational Checklists: Provides customizable or pre-made checklists for compliance with procedures like quality assurance, sanitation, and opening/closing tasks.

3. Veeva Systems

Veeva Systems provides cloud-based software solutions tailored for the life sciences industry, focusing on regulatory compliance, quality management, and clinical trials.

Their platform helps streamline processes across clinical, regulatory, safety, and commercial functions, enabling businesses to enhance efficiency and compliance in highly regulated environments.

Key Features

• Streamlined Regulatory Processes: Veeva simplifies regulatory tasks by centralizing documentation and improving communication with regulatory agencies for faster submissions and approvals.

• Improved Data Quality: Their solutions enhance data accuracy, integrity, and consistency, reducing the risk of delays or rejections during regulatory reviews.

• Faster Response to Changing Regulations: Veeva provides real-time updates on new regulations and tools to assess their impact, enabling quick adaptation to regulatory changes.

• Consolidated Quality Processes: Integrates quality management into a single system to ensure compliance with GMP and other standards, streamlining processes throughout the product lifecycle.

4. Freyr Solutions

Freyr Solutions offers end-to-end regulatory and compliance services, assisting life sciences companies with navigating global regulatory requirements.

Their solutions cover a range of services, including regulatory submissions, market access, and regulatory intelligence, to ensure efficient product compliance and market readiness.

Key Features

• Global Regulatory Services: Freyr provides end-to-end regulatory services, ensuring compliance across regions to help manufacturers navigate diverse regulatory requirements.

• Regulatory Software: Their software solutions streamline compliance processes, including submissions, labeling, and regulatory information management, making it easier to track obligations.

• Global Regulatory Intelligence (GRI): Freyr’s AI-powered GRI service offers data-driven insights to keep manufacturers ahead of regulatory changes and proactively address compliance issues.

• AI-Enabled Regulatory Advisor (Freya): Freya is an AI-driven tool that delivers verified regulatory information, helping manufacturers quickly find answers to their compliance questions.

5. SafeFood 360°

Safefood 360° offers a comprehensive, cloud-based food safety and supplier quality management platform.

It integrates HACCP, PCP, compliance management, and monitoring features to streamline food safety processes and ensure regulatory adherence across the food industry.

Key Features

• HACCP and Food Safety Plan Management: Automates the creation and management of HACCP, PCPs, and food safety plans, ensuring compliance with global standards like FSMA, ISO 22000, and GFSI.

• Supplier Quality Management: Integrates supplier management tools, including portals, document control, and traceability, to ensure compliance with regulatory and quality standards.

• Audit and Compliance Management: Provides modules for audit management and compliance tracking, helping manufacturers prepare for inspections and maintain adherence to standards like FDA and ISO.

• Traceability and Recall Management: Enables tracking of ingredients and finished products, ensuring quick response times in case of recalls or contamination, in line with FSMA and global standards.

6. SafetyChain

SafetyChain offers a digital plant management platform that provides real-time visibility into quality, production, and other critical processes.

It unifies operations across teams, helping manufacturers improve productivity, reduce waste, and ensure compliance with regulatory standards.

Key Features

• Ensure Compliance: SafetyChain helps manufacturers adhere to regulatory standards through automated workflows, process management, and instant alerts.

• Safeguard Against Costly Failures: The platform mitigates risks like product recalls and regulatory penalties, protecting the bottom line from non-compliance.

• Audit Ready Data: SafetyChain organizes data to ensure it's easily accessible and audit-ready, simplifying the audit process and reducing non-compliance risks.

• Gain Insight on Regulatory, Supplier, and Customer Relationships: The software enables manufacturers to track and manage compliance across the supply chain, including supplier performance and customer feedback.

7. Aptean

Aptean offers AI-enhanced enterprise software solutions that optimize business operations across various industries.

Their solutions include ERP, PLM, and TMS systems that improve efficiency, productivity, and visibility while addressing industry-specific challenges.

Key Features

• Food and Beverage ERP: Aptean's ERP improves traceability, recipe management, and quality control, helping ensure compliance with food safety regulations like FSMA.

• Product Lifecycle Management (PLM): Manages product specifications, regulatory requirements, and compliance documentation throughout the product’s lifecycle.

• Traceability: Enhances traceability to track ingredients and products, which is crucial for regulatory compliance and managing recalls or contamination issues.

• Quality Control: Ensures products meet industry standards and regulatory requirements by integrating quality control with traceability systems.

8. Trace One

Trace One offers PLM (Product Lifecycle Management) and compliance solutions tailored for industries like food & beverage, cosmetics, and chemicals.

Their platform enables businesses to innovate, ensure product quality, and meet regulatory requirements while driving sustainability throughout the product lifecycle.

Key Features

• Compliant Product Development: Helps manufacturers navigate and adhere to regulatory requirements throughout the product development lifecycle.

• Regulatory Compliance Cloud: A cloud-based solution for quick deployment, tracking regulatory changes, and managing compliance documentation.

• Manage Risk: Identifies and manages risk from the earliest stages of product development, helping avoid costly compliance failures and recalls.

• Trace One Regulatory Compliance: Provides regulatory news updates with custom alerts and a searchable database to stay informed on compliance changes.

9. FoodDocs

FoodDocs offers an AI-powered, all-in-one food safety management software that helps businesses implement and maintain HACCP and other food safety standards.

The platform provides customizable monitoring tasks, traceability, and automated compliance features to simplify food safety processes, save time, and ensure regulatory compliance.

Key Features

• HACCP Plan Builder: Automatically generates HACCP plans, including hazard analysis, SOPs, and flow charts, with customizable content tailored to your business needs.

• Customizable Monitoring Tasks: Offers customizable tasks and checklists with instructional guidance to ensure accurate data entry and compliance, even across multiple locations.

• Traceability and Recall Management: Simplifies traceability logs with a smart app, ensuring full supply chain traceability and quick product data retrieval for recalls.

• Compliance with Multiple Standards: It supports compliance with various food safety standards, including FSMA, HACCP, ISO 22000, and more, making it a versatile tool for regulatory adherence.

10. GAN Integrity

GAN Integrity provides an integrated compliance and risk management platform, connecting ethics, third-party risk, and regulatory programs in one place.

Their solutions help businesses streamline compliance workflows, monitor risks, and adhere to regulations like FCPA, ABAC, and ESG standards.

Key Features

• Integrated Compliance Programs: Centralizes all compliance programs in one platform, improving efficiency and reducing the risk of oversight across disconnected systems.

• Third-Party Risk Management (TPRM): Provides solutions for screening, onboarding, and monitoring third parties to ensure compliance with regulatory and ethical standards.

• Global Regulatory Compliance Support: Supports compliance with global regulations like ABAC, ESG, Modern Slavery, and more, helping manufacturers in international markets.

• Customizable and Scalable System: Offers flexibility to tailor the system to specific needs and adapt to emerging risks and regulations without extensive IT changes.

11. SGS Digicomply

SGS Digicomply offers an AI-powered, all-in-one platform for food safety and regulatory compliance, streamlining market entry and ensuring faster time to market.

It provides real-time monitoring, predictive risk management, and access to global regulatory data, helping businesses stay compliant and manage emerging risks effectively.

Key Features

• Food Safety Intelligence Hub: This tool uses AI and real-time lab data to screen food safety data, identify emerging risks, and help manufacturers stay proactive.

• Regulatory Intelligence Hub: Offers access to a comprehensive regulatory database across 150+ jurisdictions, simplifying data research and enhancing compliance efforts.

• Global Ingredient Monitor: Provides global access to legal limits and banned substances, with alerts to stay updated on regulatory changes by country and product.

• Horizon Scanning: Monitors supply chain dynamics to identify ingredient, supplier, and emerging regulatory risks, along with new business opportunities.

Why is Signify the Ideal Solution for Streamlining Regulatory Compliance?

Traditional compliance management often depends on manual tracking, disconnected documentation, and reactive risk assessments, which can expose businesses to inefficiencies and compliance risks.

Signify optimizes your compliance processes and helps your business stay ahead of regulatory changes by enabling you to:

• Monitor Compliance Continuously: Use AI-driven smart checklists to assess SOPs, labeling, and supplier documentation in real-time, identifying potential issues before they become compliance failures.

• Automate Evidence Traceability: Quickly locate and cross-reference essential compliance records, enhancing transparency, audit preparedness, and document accuracy.

• Track Regulatory Risks in Real-Time: Automatically stay updated on regulatory changes, detect risks in internal documentation, and flag potential issues before they escalate into violations.

• Test Compliance Proactively: Allow AI to continuously review compliance documentation, detect regulatory gaps early, and help you take corrective actions before they disrupt operations.

• Receive Remediation Guidance: Get clear, step-by-step instructions to address compliance gaps and stay aligned with evolving regulations and industry standards.

Ready to revolutionize your compliance approach?

Book a demo today and see how Signify can optimize your regulatory and quality workflows.