Welcome to Cert3Global

Our solutions cover a range of global regulatory compliance requirements

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Cert 3 Global gives master, sharp and involved direction for clinical devices, diagnostics, biotech, drug, and other medical organizations. We are here to provide you with a variety of regulatory documents and cGMP advisory solutions. By delivering flexible, information-based services, we specialize in assisting our clients in reducing their costs and time to market. Our worldwide regulatory experts apply up-to-date and robust regulatory knowledge to support your product development and submission plans, with regulatory expertise spanning all sorts of products. We can uphold your business achievement, by applying our mastery of the medical care market and any remaining key business sectors.

 

We know that shipping your cosmetics to another country or continent can be intimidating at first. You may be unsure of how things work and may be unsure of how to navigate a foreign regulation. Our experts can assist you throughout the process and make it as simple as possible for you. We market products that are safe, considerate of the consumer, and in accordance with applicable regulations. We are experienced regulatory experts, talented specialists, and solution-oriented consultants dedicated to assisting cosmetic brands in marketing their products and achieving global success.

MEDICAL DEVICES (EU)

The technical documentation or technical documentation MDR/IVDR is intended to demonstrate the safety and performance of medical devices

 


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The clinical evaluation report according to Article 61 of the MDR and MEDDEV Rev 4 is required for the technical documentation of the medical device and the CE certification

 


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We have found many start-ups offering new standalone medical software and they all need to be CE marked to be marketed in the EU

 
 


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Device manufacturers outside of Europe are required by law to appoint an authorized European agent to distribute the product in Europe.

 


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European manufacturers not based in the UK must appoint a UK Responsible Person (UKRP) to legally place the device on the UK market

 


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EU Regulation 2017/746 on in vitro diagnostics (IVDR) is new and many previously excluded devices are now at high risk

 


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MEDICAL DEVICES (FDA)

Let’s remove all the obstacles on the way to the pre-sale notification of a class I, II and III medical device and carefully build a chest of 510,000 pieces.

 


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If you have been looking for the best 510k consulting services, your search is over. We’ll help you reach all of your 510,000.

 
 


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We provide a hands-on service for 510K filing, consulting, US agents and FDA coordination activities for 510K clearance.

 
 


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We offer FDA registration and medical device listing services, as well as UDI filing.

 
 


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Documentation, review (internal and external) and initial FDA 510k submission can take almost 4 to 5 months. The timing also depends primarily on the device models and variants.


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DRUGS

21 CFR 211, also known as GMP, defines the minimum requirements for methods, equipment and controls used in manufacturing.

 
 
 


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The US FDA DMF is a confidential document that is voluntarily submitted to the FDA by manufacturers, processors, packers, and warehouses of human drug products.

 
 


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The US FDA controls the sale of medicines. All facilities are required to register and register medications before selling or importing these products into the United States of America.

 


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FOOD/FOOD SUPPLEMENTS

The US Bioterrorism Act requires the FDA to take steps to protect the public from harm caused by the food supply. For implementation, the FDA requires all manufacturers and importers to register their supply chain facilities.

 


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21 CFR 111 GMP is intended for those involved in the manufacture, packaging or storage of human dietary supplements

 
 
 
 


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FDA Label Verification (Food, Drug, Cosmetic) is our experts’ verification of existing labels against FDA labeling regulations

 
 
 
 


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COSMETICS

The US Bioterrorism Act requires the FDA to take steps to protect the public from harm caused by the food supply. For implementation, the FDA requires all manufacturers and importers to register their supply chain facilities.

 


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21 CFR 111 GMP is intended for those involved in the manufacture, packaging or storage of human dietary supplements

 
 
 
 


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FDA Label Verification (Food, Drug, Cosmetic) is our experts’ verification of existing labels against FDA labeling regulations

 
 
 
 


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Latest Blog


  • The Food and Drug Administration (FDA or the Agency), has published a guidance document dedicated to the

    Author Imageadmin14 June, 2023

    The Health Sciences Authority (HSA), a regulatory agency in the sphere of healthcare products, has publis

    Author Imageadmin14 June, 2023

    Quality System Procedures According to the guidance, the authority expects the applicant to submit a copy

    Author Imageadmin14 June, 2023

    Cert 3 Global commitment to product development as regulation changes stands out amongst its competitors. With Cert 3 Global we are confident that we have a partner that will evolve as our requirements also evolve.

    Gerald

  • We consider a vendor relationship to be more than just the vendor providing a product; we look for vendors who are committed to product and customer service improvement. Cert 3 Global fit that requirement perfectly.

    Davidson

  • Cert 3 Global support team has been a great asset. In the first instance, they helped us determine our data requirements, and since then they’ve always been available to help clarify and assist with any confusing compliance procedures. A top-quality vendor.

    John