Regulatory Affairs Case Studies

Curated Regulatory Intelligence Augmented by AI

Pharma and Biotech

Pharma Giant Leveraged RegASK to Proactively Monitor Regulatory Changes

The usage of dietary supplements and herbal medicine products continues to rise in several countries. However, the context of their...

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Medical Devices

Bringing Your SaMD to Market with Confidence and Compliance

Digital health is an emerging field that is revolutionizing the way healthcare is delivered. It combines technology, data, and analytics...

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Food and Nutrition

Enabling Infant Formula Brand to Expand Globally

Read the case study to find out how RegASK’s expert guidance helped an infant formula manufacturer expand into new markets....

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Food and Nutrition

Expert-Led Training: US Legislation and Enforcement of Claims on Infants & Young Children Food Products

Read the case study to know more about RegASK’s training program for legislation of claims on infants & young children...

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Animal Care

Preparing for the Launch of Pet Feed Supplements Containing Active Pharmaceutical Ingredients

Read the case study to know how RegASK assisted a pet food manufacturer to fulfill registration requirements to prepare for...

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Food and Nutrition

Obtaining Healthier Choice Logo for a Beverage Product in Malaysia

Read the case study to find out how RegASK helped a beverage manufacturer obtain the Healthier Choice Logo certificate for...

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Food and Nutrition

Monitoring CBD Regulations: When Can CBD Become a Lawful Ingredient in Food Supplements?

Read the case study to know how RegASK monitored CBD’s global market regulations to generate forward-looking market insights for food...

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Cosmetic and Personal Care

Helping a Small Team Achieve Efficiency, Accuracy, and Cost-Reduction in Monitoring Cosmetics Regulations

Read the case study to know how a small team with limited resources could monitor cosmetics regulations in an efficient,...

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Food and Nutrition

Formulation, Labeling and Packaging Compliance Checks for Entering New Markets

Read the case study and learn how an FMCG company managed to combine multiple languages in one label while expanding...

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Cosmetic and Personal Care

Successful Registration of New Cosmetic Ingredients in Japan

Read this case study to learn how RegASK’s local regulatory experts helped an international cosmetics company successfully register new cosmetic...

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Medical Devices

Regulatory Guidebooks Paved the Way for Decentralized Clinical Trials 

The adoption of hybrid and decentralized clinical trials (DCTs) has been accelerating across the world. According to Everest Group, 90%...

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Food and Nutrition

Analyzing Trends in Sweetener Labeling Regulations

Read the case study and learn how RegASK helped a food ingredient provider analyze the trends in sweetener labeling regulations...

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Pharma and Biotech

Boosting Claims for a Health Product Launch 

Read the case study and learn how a major healthcare company successfully optimized their product launch and boosted claims to...

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Food and Nutrition

Path-to-Market Success of a Novel Food Ingredient

Read the case study and learn how RegASK assessed the path-to-market feasibility of a novel food ingredient for its application...

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Cosmetic and Personal Care

Automated Regulatory Change Monitoring for a Beauty Retailer

Read the case study and learn how a cosmetics company leveraged RegASK solutions to proactively monitor regulatory changes and understand...

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Food and Nutrition

Launching a Food Supplement into China Market 

Read the case study and learn how RegASK helped an international company overcome regulatory challenges to successfully launch a food...

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Pharma and Biotech

Driving Pharmaceutical Regulatory Intelligence for Better Decision Making

Results The company gained increased visibility into the regulatory landscape impacting their product categories, along with enhanced agility and confidence...

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Pharma and Biotech

Anticipating Regulatory Risks and Opportunities in Consumer Health Industry

Read the case study and learn from this practical example how to anticipate regulatory risks and opportunities in the consumer...

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Pharma and Biotech

Decentralized Clinical Trials: How CROs can benefit from our RegGuides

As the COVID-19 pandemic continues to disrupt clinical research, there is an increased need from the pharmaceutical and CRO industry...

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Medical Devices

Supporting Global Market Access for a MedTech Company

Read our case study and learn how RegASK leveraged its strategic regulatory expertise to help a medical device company fulfill...

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Food and Nutrition

Effectively Monitoring Regulatory Changes to Increase Business Efficiency

In this article, we will explore how RegASK helps their clients automate and streamline their regulatory change management process to...

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Food and Nutrition

Navigating Food Regulations for a Successful Market Expansion

RegASK provided the client with its regulatory intelligent solution – RegALERT – to detect changes related to food regulations, and conduct...

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Cosmetic and Personal Care

How Advanced Regulatory Guidebooks Support Efficient Go-to-Market Strategies

Read our case study and know how an advanced review of the regulatory environment is fundamental to efficient go-to-market strategies...

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Pharma and Biotech

How Real-World Evidence Supported Claim Substantiation on OTC Product in Europe and the USA

A leader in the pharmaceutical industry wanted to leverage real-world evidence to bolster the claims of an over the counter...

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Medical Devices

How Product Classification Expertise was Pivotal to A Successful Market Entry

A Japanese manufacturer of support braces wanted to export its products to the E.U. market. They had a significant presence...

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ESG

Empowering ESG Intelligence with AI

  Environmental, Social and Governance (ESG) has become a business imperative for all industries and is more important than ever...

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Animal Care

How Anticipated Compliance Checks On Pet Food Labeling And Ingredient Formula Served A Successful Product Launch

A large international company in the pet food industry was looking to expand its brand into the U.S. with the...

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Cosmetic and Personal Care

Preparing for the Launch of a Hand Sanitizer during the COVID-19 Pandemic

How we helped a large MNC speed up the launch of a new hand sanitizers product. With increasing consumer demand...

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Medical Devices

A Guide to Face Mask Regulations during the COVID-19 Pandemic

How are face masks regulated? While the regulations for face masks will vary by country or region, compliance also depends...

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Home and Industrial Care

Regulatory Solutions for Disinfectants & Hygiene

Launching Hand Sanitizer in New Markets during Pandemic As consumers pay close attention to germs, demand is on the rise...

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Food and Nutrition

Regulatory Solutions for Nutritional Foods and Supplements

How We Helped a Gummy Supplement Grow Globally With a greater emphasis on preventative healthcare, consumers are increasingly buying products...

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Pharma and Biotech

Market Entry to Mexico for a Health Product

  Demand: Evaluating the Likelihood of Product Certification in the Mexican Market A large Chinese health-products company sought expansion into...

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Food and Nutrition

Achieving a Functional Food Claim in Japan for an International Beverage Company

Food with Functions Claim (FFC) Regulations in Global Markets: Acquiring FFC Approval in Japan’s Market   Challenge An American international...

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Food and Nutrition

Anticipating Regulatory Shifts for An Ingredient Manufacturer

Anticipating Changes A large ingredient manufacturer headquartered in Japan was having difficulty staying compliant in certain markets due to constant...

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Cosmetic and Personal Care

Forging Paths in New Markets for a Top Cosmetics Company

Objective A large cosmetic company wanted to expand its hair, skincare, and dietary supplement products into the top 10 skincare...

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Food and Nutrition

Preparing Leader of Infant Formula for Market Expansion

  The Challenge The client has a varied portfolio of formula milk products (infant formula, elderly nutrition drink, and sports...

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Food and Nutrition

Reviewing Product Formula for Expansion of Gummy Supplement Brand

  The Challenge A large food company is developing benefit-based gummies with unique active ingredients and wished to export them...

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Food and Nutrition

Garnering An On-Pack Health Claim For a Leading Yogurt Brand

The Opportunity A top yogurt brand recognized the need to differentiate their probiotic-rich product from the competition. The client tasked...

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Food and Nutrition

Helping a Nutraceutical Supplement Brand Grow Globally

A dietary supplement company turned to RegASK with a desire to expand. The company provided 19 different markets that it...

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