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.
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.