Authorized Agent/ Registration Holder Support

Foreign companies with no local presence trying to venture in India need to appoint an Authorized Agent/ Registration Holder. Holding a valid license, we can serve as an Authorized Agent/Registration Holder and be your in-country representative for end to-end registration processes including liaising with the regulatory authorities.

Global Manufacturers

Post Registration
Regulatory Support
Pharmacovigilance
Whole Sale
License Holder
Re-registration
License Transfer
Form 10 – Import
License Support
Form 9 – Undertaking To
Distributors And Companies

Post registration regulatory support

With years of regulatory roots, we provide post registration regulatory support to our clients. These include but are 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. etc

Pharmacovigilance

In collaboration with Pharmacovigilance companies, we help our clients 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 which need to be reported to the concerned authorities as per requirements.

Wholesale license Holder

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 can act as an authorized agent/registration holder on your behalf. Our years of experience in successful imports of products for our clients has given us valuable insights into the licensing industry which we bring to the table for our clients.

Re-registration

We help our clients file for re-registration of their products well before the prescribed time so that the license or registration certificate may stay valid and doesn’t expire.

Import License (Form 10) Support

We help our clients obtain the Import License for Import swiftly by filing the acceptable documents to the regulatory authorities enabling speedy market entry.

Undertaking to Distributors and Companies (Form 9)

Form 9 is undertaking for authorization of Indian agent or of manufacturer or registration holder and is to be submitted along with application for an Import License in Form 8 to obtain Form 10. It is required to be notarized and authenticated from the Indian Embassy of the country of origin. In case of Indian agent it won’t require attestation. We provide services as an authorized agent and also support our clients in notarization of documents from different Embassies in India.