VITALIC - Regulatory Information Management Software in Pharma By DDreg Pharma | RIMS Software

This video introduces VITALIC, a comprehensive Regulatory Information Management Software (RIMS) developed by DDReg Pharma, designed to streamline the process of bringing new drugs and biologicals to market quickly and compliantly. The core premise is that in the modern pharmaceutical world, where regulations change daily, small errors in registration tracking can cause significant, unnecessary delays. The video highlights the inadequacy of traditional, siloed, and disconnected tracking systems that leave companies without clear insight into necessary market registrations or timelines. VITALIC is positioned as the solution, developed by experienced regulatory information management professionals to help organizations deliver higher-quality data to authorities and efficiently manage the entire product lifecycle through regulatory intervention.

The platform’s primary value proposition lies in its deep, global regulatory expertise. VITALIC provides up-to-date country and regional regulatory insight, applicable across the spectrum of drug products, including consumer healthcare, generics, and biosimilars. The software meticulously covers every imaginable regulatory scenario, detailing crucial variables such as country patent status, required regulatory fees, expected timeliness of approvals, region-specific approval processes, necessary guidelines, templates, waivers, and provisions for emergency use. This level of granular detail is crucial for minimizing compliance risks and maximizing the chances of a successful launch.

DDReg Pharma leverages over a decade of experience providing global regulatory services to underpin VITALIC, claiming a 100% success rate in overcoming common regulatory challenges and noting zero filing rejections to date. This practical, real-world experience is embedded into the software, distinguishing it from other RIMS databases on the market. The company asserts that VITALIC is unique in its deep experience handling the specific agency queries and working processes of regulatory bodies across more than 130 countries worldwide. The ultimate mission of the platform is to ensure clients achieve approval the first time around by taking on the responsibility of preparing, tracking, and monitoring product submissions in defined formats, integrated with robust regulatory project management capabilities.

Key Takeaways: • Addressing Regulatory Fragmentation: The video identifies the primary challenge in pharmaceutical regulatory affairs as the use of siloed and disconnected registration tracking systems, which lead to delays and a critical lack of comprehensive insight into global market requirements. • Comprehensive Global Coverage: VITALIC’s strength is its extensive regulatory intelligence spanning over 130 countries, providing specific knowledge on how to handle agency queries and comply with the unique working processes of diverse regulatory bodies globally. • Granular Regulatory Data: The RIMS solution offers detailed, actionable insights covering specific regulatory components, including country patent information, regulatory fee structures, expected approval timelines, and necessary region-specific templates and guidelines. • Focus on Risk Minimization: The platform is explicitly designed to minimize compliance risks and maximize the probability of success by ensuring product submissions are meticulously prepared, tracked, and monitored in the precise formats required by authorities. • Accelerated Time-to-Market: By providing better data and efficient management tools, the software aims to accelerate the process of getting new drugs and biologicals onto the market, contrasting sharply with the delays caused by traditional error-prone methods. • Product Lifecycle Management Integration: VITALIC supports the efficient management of the product lifecycle through regulatory intervention, ensuring continuous compliance from initial submission through post-market activities for diverse product types (generics, biosimilars, consumer healthcare). • Experience-Backed Software: The RIMS solution is not just a database; it is built upon DDReg’s decade-plus experience and claimed 100% success rate in regulatory services, suggesting the software incorporates proven best practices and knowledge for overcoming common filing obstacles. • Regulatory Project Management: Beyond simple tracking, VITALIC incorporates regulatory project management features, ensuring a structured approach to submission preparation, monitoring, and successful product launch. • Goal of First-Time Approval: The core objective promoted is achieving regulatory approval on the first attempt, thereby eliminating costly resubmissions and minimizing the time a product spends waiting for market access.

Tools/Resources Mentioned:

• VITALIC (Regulatory Information Management Software - RIMS)

Key Concepts:

• Regulatory Information Management Software (RIMS): An enterprise solution used in the life sciences industry to manage, track, and archive all regulatory data, documents, and processes required for product registration, compliance, and maintenance across global markets.
• Product Lifecycle Management (Regulatory Intervention): The continuous process of managing a pharmaceutical product's regulatory status from early development through marketing authorization, post-market surveillance, and eventual discontinuation, ensuring all necessary regulatory filings and updates are handled efficiently.