United Kingdom
Market
European Union
Market
Driving Regulatory Excellence for Medical Devices and IVDs
CliniExperts - Your reliable partner for Comprehensive Compliance Solutions
Services CliniExperts Offer
With our knowledge of the International regulatory scenario and its intricacies, we can help you achieve your goal without any hindrances.
We offer the following regulatory services in the UK and European markets:
United Kingdom
Market
European Union
Market
USA Market
Regulatory Bodies
Navigate the complex landscape of regulatory bodies in the EU and UK markets with confidence, as we guide you towards successful approvals and compliance.
MHRA
The Medicines and Healthcare products Regulatory Agency is an agency of the Department of Health and Social Care in the United Kingdom.
EDQM
The European Directorate for the Quality of Medicines & HealthCare is a Directorate of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.
EMA
The European Medicines Agency is an agency of the European Union in charge of the evaluation and supervision of pharmaceutical products.
NRAs
NRAs are national regulatory agencies responsible for ensuring that products released for public distribution (Medical devices and IVD’s) are evaluated properly and meet international standards of quality and safety and efficacy.
About CliniExperts
Established in 2009 by Dr. Ashwini Kumar, CliniExperts is a leading provider of Regulatory and Clinical Research Services in the EU and UK. With ISO 9001 and ISO 27001 certifications, we prioritize strict adherence to Quality Management Systems and ensure top-notch standards in our services.
Our team of passionate and skilled professionals collaborates with global companies known for their high-quality products, services, and customer care. We specialize in assisting companies across various sectors, including Medical Devices and In-Vitro Diagnostics and more.
At CliniExperts, we live by our belief in unwavering quality and pursuit of excellence. Our zero-tolerance policy for defects creates a flawless regulatory ecosystem, enhancing ease of doing business for our clients.
Choose CliniExperts as your trusted partner for regulatory compliance and streamlined approvals in the EU and UK.
Certifications
ISO 9001:2015 and 27001:2013
Commitment to
Compliance
Team of Expert
Professionals
Our Happy Clients
Our Network Spans the Globe. Proudly serving for over 22 esteemed clients worldwide.
We collaborate with top-notch international companies that have a global reputation for their exceptional products, services, post-sales support, and customer satisfaction. They are dedicated to becoming an integral part of the Indian Healthcare Sector.
Testimonials
Cliniexperts are highly experienced in Indian regulatory, and the consultation provided is very quick and accurate. They are adaptable to the client needs and timely at the deliverables. We are very much satisfied with the services provided by Cliniexperts and would like to continue collaborating with them for our future research.
Ramya
Remedy
Working with CliniExperts has been an exceptional experience for our company KYOWA. Dr. Kumar and his knowledgeable team have a deep understanding of regulatory guidelines in India, coupled with their professionalism and expertise, which have greatly contributed to the success of KYOWA projects. The team at CliniExperts is dedicated, and responsive, and goes above and beyond to ensure that all aspects of regulatory compliance are met seamlessly. Their commitment to delivering top-notch services, backed by their years of industry experience, has been invaluable to our company KYOWA. We have completed numerous projects with CliniExperts, and their consistent performance and support have solidified our partnership. We highly recommend CliniExperts for its comprehensive regulatory solutions and unwavering commitment to excellence.
Read moreJaime C.
Division: Regulatory Affairs & Quality Assurance - Kyowa Hakko Bio Singapore Pte Ltd
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