The companies with no local presence trying to venture in India need to appoint an Authorized Agent/ Registration Holder. We with a valid license serve as an Authorized Agent/Registration Holder and can be your in-country representative for end to-end purposes including the liaison with the regulatory authorities.
With strong regulatory roots we provide post registration regulatory support to our clients. These includes but not limited to re-registration, renewal of license, PSUR, ADR reports, pharmacovigilance, distributor identification, regulatory compliance of labels as per new guidelines, complaint handling, query responses, product recall support, liaison with regulatory agencies and many more.
In collaboration with Pharmacovigilance companies we help our clients to monitor the effects of medical drugs and devices after approval and post marketing. It helps in the identification and evaluation of previously unreported adverse reactions for which report is to be submitted to the concerned authority as per requirements.
Indian agent must possess a valid wholesale license (Form 20B, 21B & 21C) to be an Authorized agent/Registration Holder. We hold a valid wholesale license and act as authorized agent/registration holder on your behalf and have past experience for successful import of products for our clients.
We help our clients to file for re-registration of their products well before the described time so that the license or registration certificate may stay valid and don’t expire.
We help our clients obtain the Import License, Central License for Import swiftly by filing the acceptable documents to the regulatory authorities enabling speedy market entry.
Form 9 is undertaking for authorization of Indian agent on behalf of manufacturer or registration holder which is submitted along with application for an Import License in Form 8 to obtain Form 10. It is required to be notarized and authenticated from Indian Embassy of the country of origin. We provide services as an authorized agent and also support our clients in notarization of documents from different Embassies in India.
CliniExperts offer strategic planning services for Wholesale Drug License to start with your pharmaceutical business and sell drugs at distributor level. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.
Unclear about the regulatory status of Medical Devices in India. Let CliniExperts’ professionals assist you for getting a Clarification Letter / No Objection Certificate (NOC) for Medical Devices from Central Drugs Standard Control Organisation.
ENQUIRE NOWNeed a permission to import medical device in India to demonstrate its performance? CliniExperts’ professionals have expertise and assist you in securing a medical devices test license for importers in Form MD 17 by CDSCO.
ENQUIRE NOWCliniExperts acts as an authorized representative to help you in getting the permission to import non-notified medical devices in India. Register your Non-notified Medical Devices in India with CliniExperts professional assistance
ENQUIRE NOWImporting an in-vitro diagnostic kit and selling it across the country can be overwhelming if you do not have any local establishments in India. With a well-established presence in India, CliniExperts can help you comply with CDSCO requirements and start selling your device in this emerging market. CliniExperts hold a drug wholesale license in Form 20-B and 21-B and can be your in-country representative and IVD importing a hassle-free process.
ENQUIRE NOWGet experts assistance to avail Permission to import or manufacture medical device which does not have its predicate device in India -As per MDR 2017
ENQUIRE NOWCosmetic regulatory strategy consulting & liaison by cosmetic regulatory consultant based in New Delhi, India
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