As per the notification S.O. 648(E),effective April 1, 2020, the medical devices that fall under the following definition will be regulated as “drug” under the Drug and Cosmetics Act ...
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Corelex is a well trusted company providing compliance and regulatory srvices to national and international pharmaceutical,food,biotech,cosmatics,nutraceutical and medical device companies. We are a leading regulatory affairs and compliance services company which provides for comprehensive services across the spectrum of product development, registration and commercialisation by acting as a specialised regulatory partner and a bridge between organisation and key regulators,such as CDSCO and FSSAI. Corelex is based at one of the designated industrial areas in New Delhi,at Okhla Industrial Ar...
Read MoreCoreLEX Solutions Private Limited, comprises of experienced regulatory affairs professionals, who provide complete guidance and support to pharmaceuticals, medical devices, vaccines, foods and cosmetics companies in making and execution of blueprint of regulatory strategies. Our services include assistance to organizations in expediting their product development and registration of drugs (medicines), biological (vaccines), medical devices& IVDs, cosmetics, foods items, nutraceuticals, health supplements and other healthcare products for all phases of development. Our services include: ...
From initiation to end, CoreLEX ensures complete compliance, making your route easier in various markets for your products. CoreLEX is a leading Global Regulatory Services provider for pharmaceuticals, Medical Devices, Foods and Cosmetics. With primary operating region in India, Sri Lanka, Nepal and offices around the world, CoreLEX has a large global presence to meet the requirements of clients. We provide complete dossier services for regulated market as well as rest of world (ROW) m...
Read MoreCoreLEX Solutions Pvt. Ltd. is engaged in providing a complete range of services ranging from providing Know how, Pharmaceuticals/Medical Devices plant set-up, Pharmaceuticals/Medical Devices process plant design and engineering to undertaking turnkey projects thereby managing all aspects of Project management of Pharmaceuticals, Medical Devices and Cosmetics manufacturing plant. Our technical and expert team consists of highly skilled regulatory professionals and experienced scientists...
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Thank You CoreLEX team to provide such a great regulatory services and support. An excellant team of expert Regulatory professionals for medical devices, pharmaceuticals and cosmetics products.
YEARS OF EXPERTISE
15
INTERNATIONAL CLIENTS
24
COMPLIANT PRODUCTS
150
COUNTRIES COVERED
11
Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the E...
