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Regulatory intelligence



Pharma regulatory intelligence


Less complexity. More clarity.

Regulatory intelligence refers to the process of gathering, monitoring and analyzing regulatory information and data to track developments in the changing regulatory environment. Banking, financial services, and insurance sectors continue to experience unprecedented volumes of regulatory change and complexity. Our unique one-stop Regulatory Intelligence provides world-class content and advanced technology that cuts through the complexity and the sheer volume of content and developments within the regulatory compliance environment. That’s how we can provide clarity on what is most important to your organization – in a cost effective way.


Unsurpassed breadth, depth and quality

Regulatory Intelligence includes global coverage of over 900 regulatory bodies and more than 2,500 collections of regulatory and legislative materials. It is powered by exclusive news, analysis, and practical guidance from our global team of regulatory compliance experts and journalists, and it has an intuitive user interface with powerful search functionality and easy navigation. This way, you can access whatever information you need, when you need it, from one single source.

Regulatory Intelligence Feeds incorporates our client-driven taxonomy to automate the flow of regulatory information into your organization. Content is extracted from our regulatory database – the same source that drives our Regulatory Intelligence solution. This allows for a smarter and easier workflow to be created in the application, and by utilizing our data feed in your compliance activities, you can be assured that the business is reviewing and implementing regulatory change as it occurs.


Features
Single information source
A cost-effective and simplified research process, with comprehensive content, intuitive features ,and user-friendly functionality. Focus on anticipating and navigating the regulatory environment, alongside your general day-to-day responsibilities, by taking away the burden of having to manually track and monitor multiple and varied sources of regulatory information.
More focus, less noise
Focus on the information needed to quickly reach informed and targeted decisions. Keep track of regulatory developments that specifically impact your organization through powerful features to search, filter, and automatically monitor the relevant developments.
Trusted and reliable
Our trusted global regulatory experts and editorial team, who analyze news and events on a daily basis, provide analysis and practical guidance. They provide hot topics and news and impact analysis of current and forthcoming regulations. The breadth and depth of the knowledge and expertise that goes into the collection and analysis of regulatory developments means that you consistently have access to the most thorough, accurate, and reliable regulatory information available.
Manage regulatory risk
With the shift towards bigger fines and greater personal liability, the need for organizations and compliance professionals to stay compliant has never been greater. Regulatory Intelligence reduces the potential room for errors and vulnerability within your organization by providing information that has been stringently tracked, monitored, and analyzed. Content is structured and maintained to ensure you have the most up-to-date information at all times to manage and mitigate risk.
Practical and actionable information
Thomson Reuters Regulatory Intelligence gives constant access to practical advice, best practice materials, and knowledge to implement relevant regulatory changes within your organization, and to make sure organizational structures are aligned to current and upcoming regulations. Information and reports can be created and customized for valuable and meaningful board level reporting and shared within the organization.
Concise information for a focused view
Content within Regulatory Intelligence has been configured to ensure you can easily find the relevant information to get clarity on what is most important to your organization. This simplifies the research process, as you do not have to spend time sifting through vast amounts of irrelevant information.
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What is Regulatory Intelligence (RI)?

If we will search for RI anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy and legislation. Regulatory Information collectively comprises of three main segments which are followed while performing Regulatory Information activities: • Gather Data: RI professionals perform research about regulatory norms as per a particular product in a particular geography. As far as collecting relevant regulatory information is concerned, there are a lot of sources that RI professionals leverage to consolidate their research material. • Analyse Information: This gathered data needs to be filtered out to obtain relevant information as per the purpose. The data filtered is then rearranged having relevant information required according to lat…
Certificates of Analysis (CoA)


World’s future of business is in outsourcing and globalisation EU GMP Guide Part I (Chapter 4 and Chapter 6) - these chapters contains detailed information about safety and quality, Laboratory documentation should follow the principles given in Chapter 4.EU GMP Guide Part II - Section 11.4 –§Authentic Certificates of Analysis should be issued for each batch of intermediate or API on request. §Information on the name of the intermediate or API including where appropriate its grade, the batch number, and the date of release should be provided on the Certificate of Analysis. For intermediates or APIs with an expiry date, the expiry date should be provided on the label and Certificate of Analysis. For intermediates or APIs with a retest date, the retest date should be indicated on the label and/or Certificate of Analysis. §The Certificate should list each test performed in accordance with compendial or customer requirements, including the accep…