Welcome to
pharmaREADY®
Empowering Innovation through Regulatory Excellence
At pharmaREADY®, we understand the dynamic landscape of regulatory compliance in the pharmaceutical industry. With the evolution of regulatory requirements becoming more intricate, global, and demanding than ever before, life sciences companies are facing a new era of challenges and opportunities. We're here to provide you with innovative Regulatory Technology Enabled Services that drive accelerated compliance and ensure first-time-right submissions.
Innovative Regulatory Technology to Drive Accelerated Compliance and Deliver First-Time-Right Submissions
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Customers across the globe
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Users
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Million documents handled
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Submissions managed
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SPL managed
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Unlock seamless compliance worldwide
Unleash user-friendly submissions
Enhance submissions and approvals
Elevate management & governance
Boost your global regulatory submissions!
Navigating Complex Terrain: Drivers and Constraints
In this rapidly changing environment, several drivers and constraints contribute to the increasing complexity of regulatory affairs:
Increasing Regulatory Agency Demands
Regulatory agencies around the world are raising the bar for compliance, necessitating a proactive and strategic approach to submissions.
First-Time-Right Submissions
The importance of accurate and complete submissions is paramount. Our platform ensures your submissions are on target from the first attempt.
Seamless Data Migration & Integration with Systems
Achieve seamless integration of your data and systems for efficient regulatory operations.
Cost Efficiency through Operational Optimization
Drive cost savings through streamlined processes, optimizing your operational efficiency.
Regulatory Intelligence for Evolving Requirements
Stay ahead of evolving regulatory requirements with real-time insights and intelligence.
Compliance & Faster Approvals
We help you overcome barriers to compliance and speed up the approval process.
Legacy Infrastructure & Systems
Transition from legacy systems to our cutting-edge platform seamlessly.
Lack of Resources & Optimized Processes
Address resource limitations and optimize your processes for better outcomes.
Transforming Regulatory Affairs: Challenges and Solutions
Regulatory Affairs teams face a multitude of challenges in managing submission activities within life sciences organizations.
These challenges include:
These challenges include:
Pre-Marketing Challenges
- Maintaining Product Life Cycle : We offer solutions to maintain product life cycles even without a dedicated RA team.
- Harmonizing Dossiers : Our platform ensures harmonization of dossiers, minimizing iterations and queries.
- Managing US FDA Queries : Tackle complicated queries with confidence using our expert guidance.
- Regulatory Change Management : Identify change categories and requirements effortlessly.
- Streamlined HA Correspondence : Say goodbye to manual tracking with our Regulatory Information Management (RIM) platform.
- Regulatory Promotional Expertise : Benefit from our expertise in regulatory promotional strategies for successful market launches.
- Cost Reduction and Supply Chain Management : Navigate complex supply chains and contracts while reducing operating costs.
Post-Marketing Challenges
- Quick Access to Reg. Strategists : Find regulatory strategists and teams swiftly to address post-marketing needs.
- Expert Support for FDA Queries : Gain assistance in navigating complex US FDA queries effectively.
- Ethics Committee Queries : We provide guidance on handling ethics committee queries seamlessly.
- Accelerated Approvals : Learn and implement best practices for achieving accelerated approvals.
- Evolving Approval Strategies : Develop strategies for swift approvals tailored to your product.
- Managing Resource Turnover : Overcome challenges related to resource turnover and cost management.
- Unified Technology Platform : Our integrated platform ensures your multiple technology systems work cohesively.
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Empowering Your Journey with pharmaREADY®
In addition to addressing the challenges of regulatory compliance and submission, we excel in securing IND/NDA approvals and managing products throughout their life cycles. Country-specific requirements are no longer an obstacle as we guide you through the complexities, ensuring timely submissions and approvals.
pharmaREADY® stands as a fully integrated, regulatory compliant, web-based platform that empowers you to:
- Create, view, and manage global regulatory submissions effortlessly.
- Choose between on-premise or cloud-based solutions for ultimate flexibility.
- Access real-time regulatory intelligence to stay ahead of evolving requirements.
- Streamline operations and achieve cost efficiency through optimized processes.
At pharmaREADY®, we are committed to your success, helping you compete, innovate, and execute with agility in today's competitive pharmaceutical landscape. Join us on a journey towards regulatory excellence, where compliance is a catalyst for growth and innovation.
The pharmaREADY® product suite offers four modules to help your organization meet global regulatory requirements:
pharmaREADY® DMS
A centralized Document Management System providing a collaborative workflow across departments to manage documents throughout their life cycle
pharmaREADY® TRMS
A Training Records Management System to manage and archive assessments, job specifications, and requirements as per Health Authority requirements
pharmaREADY® eCTD
Providing electronic Common Technical Document support for the publishing of Regulatory Submissions to comply with Regulatory Health Authority requirements
pharmaREADY® SPL
Comprehensive Structured Product Labeling to support label creation and management and establish registration and NDC Labeler Code
Why pharmaREADY®?
Some of the benefits that can be seen when using the pharmaREADY® product suite include:
Seamlessly Integrates all modules (DMS, eCTD & SPL, TRMS) that enables submission to be prepared in 40% less time than other systems.
