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DRUG REGISTRATION

Regulatory Affairs

China NMPA Registration/Medicine Registration

Pre-approval Registration Services:

• Pre-IND meeting, Pre-NDA meeting and scientific advice meeting

• IND application/CTA application

• BE filing for generic

• RLD filing for generic

• NDA application for innovative drug

• ANDA application for generic drug/Generic drug registration

• API CDMF filing/API registration

• Excipients CDMF filing/excipient registration

• Packaging materials CDMF filing/packaging registration

• Gap analysis for CTD dossier

• Medical translation

Post-approval Registration Services:

• Variation/Amendment submission for chemical drug and biologics

• Annual Report submission

• Registration Renewal

• One-time Import Application

• Project Filing for Narcotic and Psychotropic Drugs/APIs

Requlatory Affairs Consultation:

• Project strategies for imported drug registration

• Feasibility assessment for imported drug registration

• Chinese specific drug registration regulations consulting

• Customized training on Chinese drug registration regulations

US FDA Registration

• DMF filing for APIs, excipients, and packaging materials

• FDA Pre-IND meeting application

• FDA IND submission

• NDA submission

• ANDA submission

• Controlled Correspondence (CC) preparation

• Establishment Registration, Facility self-identification and NDC application

EU Registration

• API and excipient CEP filing

• API ASMF filing

• MA application for innovative drug

• MA application for generic drug

• CTA submission

• Scientific Advice application

• Acting as MA for the customer

• EU QP, QPPV Services

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DRUG REGISTRATION

Regulatory Affairs

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REGULATORY STRATEGIES

Efficient and accurate project strategies will be proposed by our RA &GMP experts

DRUG REGISTRATION

Pre-IND, Pre-NDA and other meetings with China Authorities

MAH SERVICES

KRB Consulting deeply understand and identify the risks and regulatory requirements of Chinese Marketing Authorization Holder (MAH) and can provide the following services to Chinese MAHs

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CONTACT

Phone number：400-0123-669

Address：A805, Tower A, Chaowai SOHO, 6B Chaowai Street, Chaoyang District, Beijing 100020

https://www.kingrabroad.com/

E-mail：info@kingrabroad.com

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KRB Consulting

DRUG REGISTRATION

Regulatory Affairs

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DRUG REGISTRATION

Regulatory Affairs

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