Regulatory Intelligence and Strategy

Maximize Your Portfolio Potential in Global Markets while Ensuring Compliance using Tech-Assisted, AI-Enabled Regulatory Intelligence Solutions and Services

Services We Offer

Our Approach to Regulatory Intelligence

Global Regulations are complex, often ambiguous. Our Regulatory Intelligence services help you access actionable insights based global regulations coupled with hands-on experience of our teams from successful registrations in past. With Artixio, command your global regulatory intelligence and policy enabling streamlined global market access regulatory strategy for successful product launch and ongoing compliance maintenance. Our team works closely with you helping you support your cross-functional team through the Regulatory Intelligence process right from information gathering, synthesis to formulating actionable insights and Regulatory Strategy.

Regulatory Information Gathering → Synthesis → Regulatory Intelligence & Strategy → Strategy Deployment

Extensive Intelligence Inputs for Actional Insights

Regulations, Guidance
Regulatory Updates, News
Translated Documents in English
Insights from Events, Trainings, Seminars
Real Time Experience
Approved Products
Translation, Legalization Requirements
Local Administrative Requirements
Forms, Checklists etc.

Actionable Insights End to End Product Lifecycle Management Strategy

Product Development
Dossier Preparation
Artwork, Label and Advertisement Promotion Material
Product Registration
Timelines and Cost
Post Approval Maintenance
Safety Compliance
Change Management and Licensing

Expert Analysis for Multi-Dimensional Intelligence

Comprehensive Coverage of Intelligence Sources:

Health Authority Websites
Health Authority Events, Seminars and Trainings
Trade Events
Regional Regulatory Experts
Artixio Projects Experience and Case Studies
Adhoc reports

Regulatory Functions Supported by Regulatory Intelligence:

Regulatory Intelligence and Policy
Regulatory Affairs
Regulatory Operations
Labelling
Artwork and Packaging
Advertisement and Promotional Materials
Chemistry Manufacturing Controls (CMC)
Regulatory Publishing
Regulatory Information Management (RIMS)

Go beyond Regulatory Intelligence Database, Artixio offers RI-Driven Strategy Development, Gap Assessment and Dossier Preparation tool to put insights into action using Dvarka.

Artixio’s Regulatory Intelligence Difference:

Globally Recognized Tech-Assisted, AI-Enabled Regulatory Intelligence Platform, Dvark
Platform Shortlisted at CPHI Pharma Awards 2024
Regional Regulatory Experts in 120+ countries
Centralized Regulatory Intelligence Specialists
Real-Time Updates
Multi-variate Analysis Enabling Regulatory Strategy Decisions
Seamless workflow using Intelligence Driven, Tech-Assisted Dossier Gap Analysis and Dossier Preparation
Cost Effective, Flexible Pricing

FAQS About Regulatory Intelligence

What are the Key Components of Regulatory Intelligence and Strategy?

Regulatory Intelligence is proactive assessment of global regulations to formulate and deploy a global product development, product registration and post approval compliance maintenance strategy. It also includes continuous monitoring of changes in regulations from Health Authorities around the world to assess the impact on business from the regulatory standpoint. Right from requirement for additional studies, changes in labelling and packaging requirements, additional testing for dangerous ingredients, product safety assurance, pharmacovigilance and other areas that can hinder the product development, registration, supply chain or business continuity.

Regulatory Intelligence includes three stages at high-level, i.e., sourcing the information, synthesis of the data, creating intelligence to formulate the strategy and deployment of the strategy.

What are the main sources of information for Regulatory Intelligence?

Health Authority website, updates are main source of data as they provide standard guidelines, notifications, news directly from the Ministries, Government and Regulatory Bodies. These sources are available online for global audience. Some countries may publish the information in local language that may need certified translation. Often some websites are delayed in relaying the complete information despite implementation of changes.

In addition, regional Trade associations, Industry Trade Events offer primary source of intelligence for potential and upcoming changes in regulations and/or insights on navigating current regulations. Often, in certain countries, these associations and events are quite useful resources as the information on HA website may not be immensely helpful to fully understand the regulations and changes.

Regional regulatory experts are a useful source of primary regulatory intelligence based on their experience and insights from their regional industry and HA network.

How do you support Global Regulatory Intelligence and Strategy?

Our global Regulatory Intelligence and Strategy support services leverage Artixio’s following capabilities:

Regional Regulatory Experts based in 70+ countries with proven experience, local professional and HA network and trade associations memberships.

Continuous monitoring of Global HA website and other relevant sources of Regulatory updates for real-time regulatory tracking

Centralized Regulatory Intelligence team of experts to track, assess, evaluate, and prepare intelligence summaries

Experience from successfully completed projects and responses to thousands of regulatory queries in global markets

Automated, AI-enabled technology platform for storage and deployment of regulatory intelligence insights for Real-Time Application across regulatory functions

What Regulatory Intelligence related challenges are faced by companies and how do you address them?

Some of the challenges faced by Companies include:

Lack of clarity on global regulations and comparison to regulated markets such as USA and Europe

Access to regulatory guidelines and updates from global HAs

Lack of access to regional insights and primary intelligence from local experts, authorities, and industry professionals

Lack of insights from practical experience of successful submissions or lifecycle maintenance

Lack of comprehensive, efficient, cost-effective regulatory intelligence platform covering major markets globally

How do you stay updated with New and Changes in existing Regulations?

We are concurrent with existing, new and changes in regulations by continuously monitoring any Health Authority updates, notifications, and announcements for announced or upcoming changes.

Our regional Regulatory Experts have decades of experience working with local HAs on diverse, complex products and have helped hundreds of products with successful navigation of regulations.

Our team members are part of regional industry network, trade associations and HA officials to proactively seek insights on potential new regulations and changes.

Using different data sources, we synthesize the insights in structured format for our partners and clients.