Regulatory Services
Overview
At Value Health Inc., we harness the power of cutting-edge technologies to automate and streamline regulatory activities throughout the biopharmaceutical lifecycle, ensuring quality and compliance from drug development to post-market surveillance. Our team of experienced regulatory professionals can tailor our services to meet your specific regulatory operational needs.
Our Vision
By employing automation across the entire regulatory spectrum, we expedite drug development timelines through streamlined submissions to all health authorities. Our customizable and cost-effective regulatory outsourcing solutions prioritize customer needs, ensuring a dependable and affordable pathway to market.
Our Approach
By incorporating AI and ML data-centric methodologies across all regulatory processes, encompassing clinical, CMC, and post-marketing surveillance activities, we significantly enhance the consistency and reliability of the process. This data-driven approach empowers us to make informed decisions, streamline workflows, and ensure compliance with evolving regulatory standards
The Benefits
- Staff Augmentation
- Regulatory Processes Automation Technologies
Automation In Regulatory Processes
At Value Health Solutions, we are shaping the future of regulatory compliance with cutting-edge AI and ML tools. We are currently pioneering projects in IDMP automation, employing Natural Language Processing (NLP) algorithms and advanced Large Language Models (LLMs) to extract and analyze regulatory data with unprecedented accuracy and efficiency.
The areas of automation
- IDMP automation
- MedDRA coding
- Publishing automation
- Submission and data management
- Protocol and ICF data automation
IDMP Automation Solutions
- Our IDMP automation tool focuses on the automation of IDMP data management using AIML technologies.
- The IMAP tool (Identification of Medicinal Products Automation Processing Tool) will open a new frontier in the automation IDMP data management while maintaining compliance and reduce the manual processes.
- We are delighted to collaborate with you in establishing an automation to your IDMP process before it becomes mandatory to move to IDMP compliance.
- Our innovative IDMP management solution will help your team in deploying the best solution for IDMP requirements with an edge on improved quality, minimal human effort at lesser cost.