Expert Regulatory Consulting for Your Success
Navigating US FDA and EU Regulations for Medical Devices and Pharmaceuticals with Ease and Affordability.
Your Partner in Regulatory Success
RegR Consultants specializes in regulatory consulting for medical devices, pharmaceuticals, cosmetics, and food industries, providing accessible and cost-effective solutions for entering the US market. In addition, we can assist medical device firms with their CE Marking Requirements.
Expert guidance and support throughout.
RegR Consultants
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Comprehensive Regulatory Support
Expert consulting for medical devices, pharmaceuticals, cosmetics, and food industries to navigate U.S. market regulations and EU CE Marking Regulation
Regulatory Consulting Services
Navigating the complex world of regulatory compliance can be challenging and time-consuming. We specialize in providing expert regulatory services designed to simplify and streamline your compliance efforts. Partner with us to turn regulatory challenges into opportunities for operational excellence. Let’s work together to ensure your business stays ahead in a dynamic regulatory environment.
Flexible Pricing Options
We understand that each client's needs and budgets are unique. To ensure you receive the best value and service, we offer a flexible pricing model tailored to accommodate a variety of requirements.
Our services
Comprehensive Regulatory Solutions for the Healthcare Industry
At RegR Consultants, we offer a comprehensive range of services tailored to the healthcare sector. We specialize in assisting medical device, pharmaceutical, and food companies worldwide in achieving regulatory and standards compliance with U.S., European, and Canadian agencies and organizations.
Our client-focused approach is built on providing expert consultants who utilize a proven, adaptable methodology. This allows us to deliver personalized solutions that address your specific needs and challenges.
Explore our full suite of services by using the navigation links on the side of this page or by clicking the links below to learn more about each of our specialized service areas.
The medical device industry in the U.S. is regulated by the FDA, requiring compliance with various standards including device registration, 510(k) premarket notification, unique device identification, electronic reporting of adverse events, and certification for foreign export.
In the pharmaceutical industry, products are regulated by the FDA based on their intended use, requiring compliance with various standards including drug registration, listing, labeling, and reporting, with additional regulations for products that may fall under both drug and cosmetic categories.
The cosmetic industry is regulated by laws like the FD&C Act, which defines cosmetics by their intended use and does not require FDA approval for most products except for color additives, though compliance with labeling and classification regulations is crucial, and the Modernization of Cosmetics Regulation Act of 2022 introduces new safety requirements.
The US FDA regulates most foods and ingredients in interstate commerce, requiring labeling for prepared foods, facility registration for food safety compliance, and provides certificates of registration, while certain exceptions like meat and poultry fall under the USDA's jurisdiction.
RegR Consultants Inc. offers comprehensive CE marking services, guiding businesses through the certification process to ensure their medical devices comply with EU health, safety, and environmental regulations, allowing them to market their products in Europe.
Discover what our clients think about our service
We had a fantastic experience working with RegR Consultants for the regulatory approval of our medical device & OTC drug products. Their expertise and clear guidance simplified the complex regulatory process, ensuring we met all necessary requirements. I highly recommend RegR Consultants to anyone seeking expert assistance in regulatory affairs.
Jimmy Narine
I am extremely satisfied with the service provided by RegR Consultants ! The service was excellent, prompt and exceeded my expectations with its quality and performance. I highly recommend RegR Consultants to everyone.
Akhil Raghuram
★★★★★
★★★★★
About us
At RegR Consultants, our mission is to empower medical device, pharmaceutical, food, and cosmetic companies to seamlessly enter the US market by providing expert regulatory consulting. We strive to deliver cost-effective, tailored solutions, guiding our clients through complex regulatory processes and ensuring compliance with global standards. Our commitment to quality, personalized service, and flexible pricing allows us to support strategic growth and success in the healthcare sector, ensuring the safety and efficacy of their products.
Contact Us
Reach out for expert regulatory consulting in medical devices, pharmaceuticals, food, and cosmetics. We're here to help.
Consulting
Expert guidance for your Regulatory Requirements
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