Regulatory Intelligence Strategy & Monitoring
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Our Approach to Regulatory Intelligence Solutions
Regulatory Information Gathering ā Synthesis ā Regulatory Intelligence &Strategy ā 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
- Regulatory Pathways
- Documentation Checklists
- Process Checklists
- Multi-Country Comparison
- Product Benchmarking
Comprehensive Coverage of Intelligence
Sources:
- Health Authority Websites
- Health Authority Events, Seminars, and Trainings
- Trade Events and Conferences
- Regional Regulatory Experts
- Pharma Wizard's Project Experience and Case Studies
- Ad Hoc 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)
Pharma Wizardās Regulatory Intelligence (RI) Services
- Globally recognized, tech-assisted, AI-enabled Regulatory Intelligence platform
- Access to regional regulatory experts in 120+ countries
- Supported by centralized Regulatory Intelligence specialists
- Real-time updates to stay ahead of global regulatory changes
- Multivariate analysis to drive confident regulatory strategy decisions
- Seamless workflows through intelligence-driven, tech-assisted dossier gap analysis and preparation
- Cost-effective, flexible pricing tailored to your needs
FAQS
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 Pharma Wizardās 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
Specialized Regulatory Affairs Services Across Multiple Industries
Expert Regulatory Services To Streamline Compliance
Get in touch
Our experts will be delighted to assist you with your global business needs.