Regulatory Affairs Case Studies
Curated Regulatory Intelligence Augmented by AI
Pharma and Biotech
FDA Guidance on Developing Chimeric Antigen Receptor (CAR) T Cell Products …
The FDA’s latest guidance outlines crucial considerations for developing Chimeric Antigen Receptor (CAR) T cell products. Focused on safety, manufacturing,...
Read morePharma 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...
Read moreMedical Devices
Bringing 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...
Read moreFood 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....
Read moreFood and Nutrition
Expert-Led Training: US Legislation and Enforcement of Claims on Infants …
Read the case study to know more about RegASK’s training program for legislation of claims on infants & young children...
Read moreAnimal Care
Preparing for the Launch of Pet Feed Supplements Containing Active Pharmace…
Read the case study to know how RegASK assisted a pet food manufacturer to fulfill registration requirements to prepare for...
Read moreFood 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...
Read moreFood and Nutrition
Monitoring CBD Regulations: When Can CBD Become a Lawful Ingredient in Food…
Read the case study to know how RegASK monitored CBD’s global market regulations to generate forward-looking market insights for food...
Read moreCosmetic and Personal Care
Helping a Small Team Achieve Efficiency, Accuracy, and Cost-Reduction in Mo…
Read the case study to know how a small team with limited resources could monitor cosmetics regulations in an efficient,...
Read moreFood and Nutrition
Formulation, Labeling and Packaging Compliance Checks for Entering New Mark…
Read the case study and learn how an FMCG company managed to combine multiple languages in one label while expanding...
Read moreCosmetic 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...
Read moreMedical 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%...
Read moreFood 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...
Read morePharma 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...
Read moreFood 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...
Read moreCosmetic 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...
Read moreFood 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...
Read morePharma 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...
Read morePharma 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...
Read morePharma 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...
Read moreMedical 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...
Read moreFood 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...
Read moreFood 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...
Read moreCosmetic and Personal Care
How Advanced Regulatory Guidebooks Support Efficient Go-to-Market Strategie…
Read our case study and know how an advanced review of the regulatory environment is fundamental to efficient go-to-market strategies...
Read morePharma and Biotech
How Real-World Evidence Supported Claim Substantiation on OTC Product in Eu…
A leader in the pharmaceutical industry wanted to leverage real-world evidence to bolster the claims of an over the counter...
Read moreMedical Devices
How Product Classification Expertise was Pivotal to A Successful Market Ent…
A Japanese manufacturer of support braces wanted to export its products to the E.U. market. They had a significant presence...
Read moreESG
Empowering ESG Intelligence with AI
Environmental, Social and Governance (ESG) has become a business imperative for all industries and is more important than ever...
Read moreAnimal Care
How Anticipated Compliance Checks On Pet Food Labeling And Ingredient Formu…
A large international company in the pet food industry was looking to expand its brand into the U.S. with the...
Read moreCosmetic 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...
Read moreMedical 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...
Read moreHome 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...
Read moreFood 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...
Read morePharma 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...
Read moreFood and Nutrition
Achieving a Functional Food Claim in Japan for an International Beverage Co…
Food with Functions Claim (FFC) Regulations in Global Markets: Acquiring FFC Approval in Japan’s Market Challenge An American international...
Read moreFood 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...
Read moreCosmetic 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...
Read moreFood 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...
Read moreFood 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...
Read moreFood 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...
Read moreFood 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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