How Matrix Pharma Achieved Seamless Submissions with pharmaREADY

The pharmaceutical industry is at a turning point in how it manages regulatory submissions. Agencies across the world, from the U.S. Food and Drug Administration (FDA) to the European Medicines Agency (EMA), are demanding structured and timely submissions. Companies that continue relying on legacy publishing systems risk operational bottlenecks, compliance failures and even delayed market access.

Regulatory Information Management (RIM) systems have become the backbone of compliance. According to Grand View Research, the global RIM market was valued at USD 2.02 billion in 2023 and is projected to reach USD 4.12 billion by 2030, expanding at a CAGR of ~10.4%. Looking further ahead, Future Market Insights projects that the RIM market will grow from USD 2.39 billion in 2025 to USD 6.79 billion by 2035, at a CAGR of ~11%.

Against this backdrop, Matrix Pharma Corp. made a strategic move to replace their existing docuBridge platform with pharmaREADY^® eCTD, hosted in Navitas’ secure cloud environment. This decision was about future-proofing their regulatory operations for an era defined by global harmonization and accelerated approvals.

Matrix Pharma’s Transition to pharmaREADY^®

Matrix Pharma was operating on docuBridge, a legacy eCTD publishing tool. With an expanding portfolio and the responsibility of filing across multiple health authorities, the company needed a solution that could handle both volume and complexity without disruption.

Key Aspects of Implementation

Navitas Life Sciences partnered with Matrix Pharma to deliver a structured, collaborative transition to pharmaREADY^®.

• Platform Replacement:docuBridge was decommissioned and replaced with pharmaREADY^® eCTD .
• Cloud Deployment: Implemented on Navitas’ secure pharma cloud platform, eliminating infrastructure burdens.
• Data Migration: ~75 GB of submission data successfully transferred from Matrix Pharma’s environment to the Navitas cloud.
• Sequence Migration: Using Navitas’ import tool, more than 9,000 sequences were migrated seamlessly from docuBridge into pharmaREADY^®.
• Regulatory Coverage: Configured for submissions to 11 global agencies, including USFDA, EMA, Health Canada, Swissmedic, TGA, SAHPRA, MHRA, MCC, GCC, Jordan FDA, and Thai FDA.
• Quality Assurance Alignment: Navitas provided documentation and worked with Matrix Pharma’s IT-QA team to meet internal compliance and process validation standards.
• Ongoing Support: Annual support model, including guidanceduring live submissions and rapid resolution of technical challenges.

Success Factors

• Timeline Adherence: Navitas delivered the implementation within the agreed schedule, ensuring continuity of live submissions.
• Process Integration: Close collaboration with IT-QA ensured the transition aligned with internal procedures and passed all compliance checks.

Customer Testimonial

One of the strongest validations of success comes directly from the customer. Dr. Sudarsan KG, Vice President of Corporate Quality at Matrix Pharma Corp., shared his experience in a testimonial.

This customer feedback highlights the technical success of the migration, the trust and responsiveness that defined the collaboration. For Matrix Pharma Corp, Navitas was a partner ensuring continuity in live submissions.

pharmaREADY^® is a Regulatory Technology Enabled Services platform designed to empower innovation through regulatory excellence. It is used by global pharma, biotech, and generics companies to simplify submissions, ensure compliance, and scale regulatory operations.

Core Capabilities

• First-Time-Right Submissions: Automated validation and harmonization reduce rework and agency queries
• Seamless Data Migration: Designed to handle high-volume data transfers without operational downtime.
• Cloud-Native Agility: SaaS platform ensures scalability, security, and reduced infrastructure costs.
• Regulatory Intelligence: Real-time updates on evolving regulatory requirements across global markets.
• Global Submissions: Proven track record of supporting filings across all major health authorities.

Industry Drivers and Constraints

Several macro trends are driving the need for regulatory modernization:

• Increasing Regulatory Demands: Agencies are raising the bar for dossier quality and structure.
• Globalization of Submissions: Companies must harmonize submissions across multiple agencies simultaneously.
• Cost Pressures: With rising R&D costs, regulatory functions must deliver efficiency gains.
• Talent Shortages: High turnover in regulatory teams makes process automation and support more critical.

pharmaREADY^® addresses these by offering:

• Pre-Marketing Solutions: Harmonization of dossiers, life cycle management, FDA query handling.
• Post-Marketing Solutions: Streamlined change management, faster approvals, and resilience to resource turnover.
• Operational Optimization: End-to-end integration reduces manual tracking and accelerates approvals.

How Pharma and Biotechs Can Leverage pharmaREADY^® Like Matrix Pharma

Matrix Pharma’s journey is a blueprint for success that other pharma and biotech companies can learn from. Their transition to pharmaREADY^® eCTD demonstrates how forward-thinking organizations can strengthen compliance, accelerate submissions, and future-proof their regulatory operations.

Three Key Takeaways for the Industry

• Technology Modernization is Inevitable: With the global RIM market projected to grow at 11% CAGR through 2035, modernization is a business imperative.
• Cloud Adoption is Mainstream: On premise solutions are rapidly declining. Cloud-first strategies are now defining the future of regulatory affairs, offering scalability, resilience, and efficiency.
• Customer Validation Builds Trust: Real-world testimonials, like the one from Matrix Pharma’s Vice President of Corporate Quality, Dr. Sudarsan KG, provide the most credible proof of impact, reinforcing why pharmaREADY^® is trusted worldwide.

By adopting pharmaREADY^®, pharma and biotech companies can not only meet today’s compliance demands and build the regulatory agility required for tomorrow.

Matrix Pharma is now positioned to manage global submissions with agility and confidence. Their ability to file with 11 agencies through a single cloud platform demonstrates the strategic advantage of regulatory modernization

As agencies move toward eCTD v4.0, structured data submissions, and greater reliance on regulatory intelligence, early adopters like Matrix Pharma will be better prepared for the future.

For Navitas Life Sciences, this success reaffirms the role of pharmaREADY^® as a catalyst for regulatory excellence, enabling sponsors to ensure seamless compliance, accelerate approvals and bring medicines to patients faster.

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