Your Partner in Quality and Regulatory Compliance
Quality Management System Set up
ISO 13485:2016
ISO 9001:2015
EU Regulatory and CE Marking
Prepare and Submit MDR and IVDR Technical File
IVDR Transition
FDA Related Services
FDA Registration
Device Listing
USA FDA Agent
FDA QSR
UDI System
FDA GUDID
EUDAMED Submission
Regulatory Strategy, Gap Analysis & Classifications
Preparation for FDA and ISO Inspection/Audits
Suppliers Audit Internal Audit
What We Do
Operating for more than a decade, Regulatory Solutions, Inc. has been ensuring that businesses become fully compliant with all regulatory guidelines for their medical devices. We also assist them with registering their facilities with different regulatory agencies as well as prepare and submit applications for all kinds of required certificates in an effective and efficient manner.
Medical Device Global Regulatory Compliance With Our Help
Regulatory Solutions, Inc. is a one-stop shop for all your regulatory assistance needs. We are highly experienced in giving consultations on global compliance to U.S.-based, foreign, and OEM-based companies that manufacture and supply in vitro diagnostic technologies and other medical devices.
Personalized Solutions
We believe that our clients’ needs come first. With this in mind, we are committed to developing regulatory strategies that are tailored to their companies’ specifications. By doing this, we can help them achieve their goals of expanding their business and reaching a global market.
Maintaining Compliance
We always strive to make sure that all compliance requirements are fully met by our clients at all times. To do this, we regularly work with various notified bodies, competent authorities, European authorized representatives, the FDA, ISO, and other global regulatory organizations.
Global Regulatory Solutions
Regulatory Solutions, Inc. also assist with registration in international markets.
Schedule a Consultation With Us
Trust on us to help you accomplish any compliance requirement for your business. Feel free to contact us today if you are interested to work with us. We serve biotech companies worldwide.
FDA Certification Registration Services
The United States government regulates public health with products through the Food and Drug Administration (FDA). If you want to sell a new product, such as a food, drink, medicine, or beauty product, you need to register it with the FDA.
However, many people are intimidated by this process and the paperwork that it involves. At Regulatory Solutions, Inc., we offer FDA registration services to help you remain compliant with the government.
By certifying your product with the FDA, more people are also more apt to purchase it. Many people look for FDA registration listed on the products they purchase to give them peace of mind that the item is safe to use for themselves and their loved ones. Therefore, you can increase your sales by completing this process.
For more information on our FDA certification registration services, contact Regulatory Solutions, Inc. You can call us at (818) 431-0423 or book a consultation online.
