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Compliance Solutions
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.
Solutions
We provides services for companies developing or manufacturing medical devices regulated under the United Kingdom (MHRA), United States Food and Drug Administration (US FDA), European Union Medical Device Regulation (EU MDR), and International Organization for Standardization (ISO).
Medical Device
We provide a wide range of services for large, medium, and small cosmetics and personal care industries to make sure their products comply with the most recent cosmetic safety regulations.
Cosmetics
FDA Guidance on QSI
Facet Screw Systems – FDA Guidance
HSA Guidance
What we can do
EU CE Marking
UK CA Marking
USA FDA
MDR Planning & Execution
IVDR Planning & Execution
MDR Clinical Evaluation
IVDR Clinical Evidence
Medical Device Consultancy
Medical Device Regulatory Consultancy
What our clients are saying
“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
“We have been consistently impressed with Cert 3 Global constant dedication to ensuring that our compliance needs are met. We would recommend them to any firm looking for a market abuse or best execution solution.”
Paul
“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.”