RegASK

Do less, know more, and empower your regulatory decisions with solutions empowered by AI

RegASK is a global, RegTech company, automating regulatory research to empower informed strategies. Operator to help firms’ International Trade, Regulatory and Government Affairs become a more proactive player and key contributor to marketing and strategic decisions by facilitating compliance in global markets through innovative powered-by-Artificial Intelligence SaaS solutions, supported by outst

French Food Agency Releases Scientific Nutrition Advice To Avoid Gain Weight | RegASK 06/07/2024

🍽️ RegAlert! New Scientific Nutrition Advice from ANSES French Food Agency to Avoid Weight Gain 🍽️

On May 29, 2024, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) released crucial nutrition advice focusing on the temporal distribution of food intake. Read more on https://hubs.la/Q02zYpvn0

French Food Agency Releases Scientific Nutrition Advice To Avoid Gain Weight | RegASK ANSES released crucial nutrition advice focusing on the temporal distribution of food intake. Read more

05/30/2024

🚀 Exciting News from RegASK! 🚀

📈 Ready to Transform Your Regulatory Operations? RegASK is thrilled to announce the launch of RegGenius, our AI-driven agent designed to revolutionize how organizations navigate the ever-changing regulatory landscape.

🌍 Global Reach, Local Precision RegGenius offers a suite of cutting-edge AI capabilities that provide tailored and actionable regulatory insights, streamline workflows, and enhance regulatory strategy ex*****on.

💡 Key Features:

🔶GenAI Conversational Agent: Instant answers to specific regulatory questions, tailored to your organization's context.

🔶AI-Driven Translation: Seamless translation of regulatory documents to bridge language barriers.

🔶Intelligent Content Creation: Automatic generation of regulation titles, summaries, and actionable insights.

🔶Augmented Analytics: Deep insights into regulatory data and trends for better decision-making.

🛡️ Your Intelligent Regulatory Partner RegGenius leverages retrieval-augmented generation (RAG) to ensure context-aware information delivery, maintaining your organization's data privacy while providing accurate and relevant insights.

Shleifer CEO of RegASK, emphasizes, "RegGenius is not just a suite of tools. It's an intelligent partner that empowers regulatory teams to be more proactive, confident, and strategic, unlocking a competitive edge and growth opportunities."

"Today's regulatory environment is more dynamic and complex than ever," says Reghimi, our Chief Product and Technology Officer. RegGenius empowers regulatory professionals with the information that matters most, right at their fingertips.

Explore how RegGenius can enhance your regulatory compliance and intelligence by visiting https://hubs.la/Q02yXzc-0.

03/08/2024

At RegASK™, we firmly believe in the strength of women and men coming together to uplift and inspire one another.

On International Women's Day, we are proud to celebrate all women in our RegASK team and beyond. We want to spotlight our women in tech working passionately behind the scenes driving forward our platform from to user experience.

We are proud to celebrate all women in : the incredible women who pioneered the first advancements in , the women leaders we work alongside who drive forward , and the next generation of women who inspire the future.

Women across the globe possess remarkable power to foster resilience, determination, innovation, and courage in all of us. Join us in celebrating , as we embrace inclusion, diversity, and the invaluable contributions of women.

03/07/2024

February was fruitful at RegASK!

We kicked off the month with our TownHall.

Our CEO Caroline Shleifer ignited the spirit of innovation and passion and took us from reflections of 2023 to the forward-thinking vision of 2024 and beyond.🚀

Amenallah Reghimi, our CPTO, mapped out the exciting Product roadmap ahead, presenting our new features coming up. With our colleagues from all over the globe, we had fruitful workshops about the pivotal role of Regulatory Affairs and how using Generative AI is enabling the emergence of the Augmented Regulatory Affairs which is poised to redefine the pivotal role of Regulatory Affairs.💡

We celebrated our Innovation Challenge winners, re-affirming our values of creativity and passion embedded in our company culture. 🔮

Our collaborative strength strengthened by diverse backgrounds allow us to focus on delivering excellence in regulatory insights and great customer experience.

We also welcomed the start of the Year of the Dragon and the birthdays of our incredible February team members, reinforcing the sense of community that propels us forward. 🐉🎂

🚀

03/06/2024

🚀 Elevate Your Regulatory Intelligence Strategy with RegASK™🚀

Experience the power of precision with RegASK—an innovative solution designed to streamline your regulatory workflow and amplify your efficiency. 🌐✨

Monitor effortlessly changes in regulations within your scope with your personalized dashboard, . RegASK filters the noise and refines your alerts to ensure they align perfectly with your focus areas. 📊🔍

Our platform empowers you to stay ahead of the curve by providing actionable insights from our industry experts. Don't just navigate regulatory changes; anticipate and adapt with confidence. 💡💼

Identify emerging regulatory trends effortlessly with RegASK, enabling you to make informed decisions that impact your business positively. 📈✅

And the best part? RegASK transforms complex regulatory updates into personalized and visually engaging newsletters for your teams—in mere seconds. Share insights seamlessly and keep your stakeholders informed. 📧👥

Discover how RegASK can be your strategic ally, saving you valuable time while driving tangible regulatory value. Visit https://hubs.la/Q02nqNKP0 to learn more. ⏳💻

🌐
"

03/05/2024

Are you heading to the 2024 RAPS Global Regulatory Strategy Conference tomorrow? Be sure to connect with Kurt Stewart and Joe Sullivan in the foyer outside the main conference hall!

We are a proud Silver Sponsor of the Conference, and look forward to sharing how RegASK™ tech, driven by AI, will help you and your organization get ahead of regulatory changes across the globe.

Learn more: https://hubs.la/Q02mZMbR0

02/29/2024

🚭 Since January 1st, Australian pharmacies can no longer advertise the availability of prescription ni****ne to their customers. The Therapeutic Goods Administration (TGA) repealed the Advertising Permission for Ni****ne, as part of its ongoing reforms to regulate va**ng products.

Request a demo of RegASK to experience the latest global regulatory alerts in the pharmaceutical industry at your fingertips: https://hubs.la/Q02mLzf_0

**ng

02/28/2024

We'll be at the 2024 RAPS Global Regulatory Strategy Conference on March 6th & 7th!

We hope you'll stop by the RegASK display to discover how AI-driven insights can help you set the right strategy to stay ahead of regulatory changes, from the smallest markets to major cities.

➕Innovative SaaS Solution
➕Automated Regulatory Monitoring
➕A Community of 500+ Experts
🟰Informed Strategies

Two of our team members, Kurt Stewart and Joe Sullivan, will be on hand to discuss how you can leverage our AI-driven technology to get the answers you need. Let's connect!

02/27/2024

🏀⚾️🧢 To promote responsible consumption of food in different exercise scenarios, Colombia's Ministry of Health and Social Protection has announced new requirements for sports foods in a Regulatory Impact Report.

The change will impact several aspects of sports food regulations, including:
👉definition
👉classification
👉composition requirements
👉labeling and advertising
👉registration process
👉inspection criteria

Learn more about this RegALERT: https://hubs.ly/Q02mq42h0

02/23/2024

Do you want to unlock a new market in the EU, but you're unsure if your product will pass European product classification standards?

Take a closer look at how RegASK™ helped our Japanese client swiftly navigate product classification and ensure compliance, and find success in the EU! 🚀

If you're expanding to a new market, we will help you be confident in your compliance. Learn more: https://hubs.la/Q02m3Mm70

02/22/2024

👨‍👩‍👧‍👦 A new study from the UK's Medicine and Healthcare products Regulatory Agency (MHRA) suggests an increased risk of neurodevelopmental disorders in children whose fathers took valproate - an anticonvulsant (or anti-epileptic) medicine - in the three months prior to conception.

Learn more about the precautions and new safety measures being introduced in the UK for valproate with RegALERT: https://hubs.ly/Q02lX45P0

Photos from RegASK's post 02/21/2024

As a Silver Sponsor of the 2024 RAPS Global Regulatory Strategy Conference on March 6th and 7th, we're looking forward to showcasing how you can:
👉 Strategize with RegINSIGHTS
👉 Detect with RegALERTS
👉 Comply with RegASK

Why wait? Connect with Kurt Stewart and Joe Sullivan to arrange a one-on-one consultation to explore the range of RegASK™ products available for both you and your organization.

02/20/2024

Effective immediately, the Taiwan Food and Drug Administration has enacted stringent regulations and labeling rules for four key food raw materials: Devil’s Claw Leaves, Gerbera Stemmed Chrysanthemum, Noni Leaves, and Psyllium Husks.

Stay informed about these vital changes as the Taiwan FDA takes proactive measures to ensure the highest standards in food safety and regulation: https://hubs.la/Q02lHnDF0

02/15/2024

ANVISA, Brazil has introduced new procedures for importing experimental medicines for clinical research and those for assistance programs. The updated flow eliminates pre-boarding inspections for drug products without controlled substances under Ordinance SVS/MS 344/1998. For such cases, post-shipment inspection suffices. Medicines under special control still require pre-boarding procedures.

Missed this alert? Read more: https://hubs.la/Q02lglXr0

Book a demo with us today and stay ahead.

02/15/2024

At RegASK, we're committed to empowering you.

Keep your executive team fully informed, and gain a competitive edge, by setting the right strategy to stay ahead of regulatory changes.

Our cutting-edge regulatory intelligence management solution - RegASK - exists to revolutionize regulatory compliance and strategy.

We are a Silver Sponsor of the RAPS Global Regulatory Strategy Conference 2024. Chat with Kurt and Joe on March 6th & 7th to uncover the power of AI-driven insights and what we can do for you.

10/23/2023

The medical device landscape is rapidly evolving, and regulatory compliance is paramount. Need help deciding on the right pathway?
✅ 510(k) Pathway: For devices similar to already marketed ones.
✅ De Novo Pathway: For novel, low-to-moderate risk devices.
✅ PMA Pathway: For high-risk devices or those with no existing predicates.
Ready for a smooth medical device submission? 📑
Let guide you through this regulatory maze: https://hubs.la/Q0264-sV0

The Ultimate Guide to Medical Devices Submission Pathways | RegASK 10/16/2023

Did you know that medical devices have specific FDA submission pathways?

From the 510(k) and De Novo to the PMA pathway, understanding and navigating these processes are crucial for a seamless transition from development to market entry.
🔍 Dive deep into our latest article to gain comprehensive insights into each pathway and why they matter for manufacturers: https://hubs.la/Q025zCqN0

Partner with RegAsk for a seamless regulatory journey.

The Ultimate Guide to Medical Devices Submission Pathways | RegASK Discover more on how the FDA's 510(k), De Novo, and PMA pathways offer distinct regulatory routes based on their device's risk profile and similarity or novelty compared to existing devices. | RegASK

10/12/2023

Regulatory compliance is an essential part of business practices. 📈

➡️ With operations in place to navigate compliance changes, businesses become more resilient and can navigate changes.
➡️ Maintaining continuous compliance monitoring and management can ensure they remain within industry requirements.
➡️ Staying proactive is crucial to avoid issues and maintain a positive reputation within your industry.

💡RegAsk offers solutions to make this easier.
How? Our technology flags regulatory changes and provides updates in real time to allow businesses to stay ahead of the curve.

Read more about how regulatory change monitoring can help your business via : https://hubs.la/Q024qPPt0

10/11/2023

Malaysia has released its first Decentralised Clinical Trial guidance document, which provides detailed guidance on implementing decentralized elements in clinical trials.

The document outlines how companies can incorporate DCT into their research while setting key parameters, rules, and expectations. Learn more: https://hubs.la/Q0245_WH0

10/09/2023

China Food Safety Regulations updates!

The 85 national food safety standards include 3 product standards, 5 GMP standards, 6 food-related product standards, and 46 test method standards. While, the 3 amendment documents on food additives standards.

Learn more on RegASK: https://hubs.la/Q0245WS30

10/06/2023

Did you know?

An NIH-funded team has developed a miniature device with the potential to predict the therapeutic option that will work best for a given tumor, changing the narratives for the approximately 25,000 people diagnosed with brain cancers in the U.S. each year: https://hubs.la/Q0245mdH0

10/05/2023

Medical device companies must navigate a complicated and rapidly changing regulatory landscape. Regulatory bodies such as the FDA, the European Medicines Agency (EMA), and others, are constantly updating and introducing new regulations to support the safety and well-being of users. To ensure their products meet compliance standards, medical device companies must regularly monitor for updates.

The most efficient way to stay on top of the latest developments is to utilize technology-powered platforms that alert businesses of regulatory changes. RegASK’s goal is to streamline the monitoring process and provide medical device companies with the information they need to keep their products on the market.

Read the full article here: https://hubs.la/Q024qJmf0

10/04/2023

Mexico follows the World Health Organization's recommendation to eliminate trans fats. The new provision of the General Health Law that restricts trans fats entered into force on the 20th of September.

More details can be found on the RegASK Platform: https://hubs.la/Q0245ktk0

FAO's The State of Food Security and Nutrition in the World 2023 | RegASK 10/02/2023

The "State of Food Security and Nutrition in the World 2023" by FAO is out now!

🤔 Do you know how these insights impact your business?

Dive into the latest global trends, challenges, and food security and nutrition solutions. Contact RegAsk to discover more about the implications for your operations and strategies.
Learn more:

FAO's The State of Food Security and Nutrition in the World 2023 | RegASK This report provides an update on global progress towards ending hunger and malnutrition, as well as estimates on the number of people who cannot afford a healthy diet...

A framework of design for AI-enabled regtech - Thomson Reuters Institute 09/29/2023

To no surprise, the integration of Artificial Intelligence is reshaping regulatory compliance 🤖

This integration offers the potential for significant benefits in terms of insights, cost-efficiency, and reduced burdens. However, this integration should be approached carefully, considering the complexities and implications it brings to traditional regulatory frameworks.

Read more on the need for a holistic and sustainable approach that integrates AI, regulatory technology (regtech), and human expertise 👉 https://hubs.la/Q020Mljc0

At RegASK, we’re at the forefront of AI-powered regulatory support, so contact us now: https://hubs.la/Q020MkfZ0

A framework of design for AI-enabled regtech - Thomson Reuters Institute AI is all the rage for rule-making bodies — yet it's critical to define innovative frameworks to AI-enabled regulatory compliance.

Will 2023 be the year food plays a role in sustainability policy? 09/27/2023

The 2022 United Nations Climate Change Conference (COP27) marked a pivotal shift, with agriculture and food systems taking center stage in climate discussions 🌎

Traditionally, the focus on climate change has been on industries like factories and vehicles. But there has been a growing recognition of the food sector’s significant contributions to climate change as it represents approximately 1/3 of all emissions. 🤯

To understand how this is affecting your company, check out this link 👉 https://hubs.la/Q020MhVS0

Will 2023 be the year food plays a role in sustainability policy? Policymakers are starting to connect the dots between the sector — which represents roughly a third of all emissions — and climate change. But traditional ideas about food are hard to change.

09/26/2023

Introducing the brilliant minds behind RegASK, your ultimate partner in conquering regulatory challenges! 🌟

RegASK is made up of an exceptional team of regulatory experts, dedicated to guiding you through the intricate maze of compliance. 🚀 With decades of combined experience, we specialize in decoding the ever-evolving landscape of regulations, ensuring your success in the complex world of business.

Connect with us today to explore how RegASK can transform your regulatory journey 👉 https://hubs.la/Q020McQx0

09/22/2023

Are you expanding to new markets or new product categories for your life sciences products? Do you need to understand the key aspects of life sciences regulations? If your answer is YES, then our Guidebooks are what you need!

RegASK’ Go-To-Market Regulatory Guidebooks provide a practical overview of the regulatory landscape and compliance requirements for life sciences products per country 🌎

The regulatory topics are:
🔬 Compositional standard regulations
🔬 Labelling, advertising, and promotional regulations
🔬 Registration process and requirements
🔬 Important requirements
🔬 and more…

Contact us to get a copy of the Guidebook 👉 https://hubs.la/Q020MmCW0

09/21/2023

🔬The future of clinical trials is decentralized, but the regulations are still catching up!

Due to factors like the COVID-19 pandemic and demand for faster, cheaper drug trials, the market for decentralized clinical trials (DCTs) is projected to grow significantly. 💊 Along with this, the regulatory environments are also evolving.

The future of DCTs involves increased regulatory acceptance, evolving regulations due to advancing technology, and emphasis on data privacy. 🔐

Read our blog to discover the benefits that accompany the increasing DCT market and its regulations 👉 https://hubs.ly/Q020MgPf0

09/19/2023

How can you successfully and efficiently launch a medical device app in several countries?

A global digital mental healthcare provider sought to launch a Cognitive Behavioral Therapy (CBT) app in several Asian countries, including Hong Kong, Malaysia, and Thailand. 🌏 But first, they had to understand the regulatory landscape, potential restrictions, and the best commercializing pathway.

RegASK conducted a thorough analysis of the regulatory framework and provided the client with critical insights, enabling them to design an effective strategy for successful product launch while saving time and effort. 🙌

💭 Are you planning to launch any medical devices? Do you need to understand the key aspects of medical device regulations (MDR)?

Check out this case study to learn how RegASK can assist you in all regulatory aspects of MDRs 👉 https://hubs.la/Q020McG60

Want your business to be the top-listed Business in Florida City?
Click here to claim your Sponsored Listing.

Our Story

RegASK started as a team of regulatory strategy experts for our parent company, SPRIM, a life-sciences consulting agency. As regulations grew more complex, our team recognized the arduous, often slow and expensive process to find accurate answers to regulatory inquiries. This was the genesis of RegASK –a digital platform to automate the research.

With the emergence of technologies like Natural Language Processing and AI, we realized we could leverage technology to automatically scroll the regulations, reducing the time and cost for regulatory affairs.

In 2018, we received venture capital funding and started developing our platform.

Videos (show all)

🚀 Exciting News from RegASK! 🚀 📈 Ready to Transform Your Regulatory Operations? RegASK is thrilled to announce the launc...
February was fruitful at RegASK! We kicked off the month with our TownHall. Our CEO Caroline Shleifer ignited the spirit...
🚀 Elevate Your Regulatory Intelligence Strategy with RegASK™🚀 Experience the power of precision with RegASK—an innovativ...
🚭 Since January 1st, Australian pharmacies can no longer advertise the availability of prescription nicotine to their cu...
🏀⚾️🧢 To promote responsible consumption of food in different exercise scenarios, Colombia's Ministry of Health and Socia...
Do you want to unlock a new market in the EU, but you're unsure if your product will pass European product classificatio...
👨‍👩‍👧‍👦 A new study from the UK's Medicine and Healthcare products Regulatory Agency (MHRA) suggests an increased risk o...
Effective immediately, the Taiwan Food and Drug Administration has enacted stringent regulations and labeling rules for ...
ANVISA, Brazil has introduced new procedures for importing experimental medicines for clinical research and those for as...
💄Efficient cosmetic product facility registration and listing is now possible through the U.S. Food and Drug Administrat...
#CaseStudy: A Winning Market Entry Strategy for a Healthcare Company Learn how RegASK leverages its regulatory consultin...
It's finally Christmas time! The RegASK team wishes you a Merry Christmas! 🎄🎅🎁 We hope that your holiday will be filled ...

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247 E. Eau Gallie Boulevard , #331 Indian Harbour Beach
Florida City, FL
3293

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