OTC / Drug Notification (Registration) and Certificate

    

Global Regulatory Affairs Consulting Agency, KGMP CORP.

OTC / Drug Notification (Registration) and Certificate

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

KGMP is a trusted leader in drug and OTC consulting, providing expert guidance to navigate market-specific requirements and ensure compliance with local and global regulations, facilitating safe export and distribution.

OTC / Drug Notification (or Registration) Compliance: Essential Insights for Your Business

Drug notification (or registration) is a critical regulatory requirement to ensure patient safety and market compliance. This process verifies a drug’s safety, efficacy, and adherence to regulatory standards, enabling healthcare professionals and patients to make informed decisions. (QSR).

For markets requiring registration, securing regulatory approval is essential to prevent compliance risks, such as import delays, fines, recalls, or market restrictions.

Our expertise in global regulatory frameworks helps you navigate complex approval processes and align with your target market’s regulatory expectations.

KGMP OTC / Drug Notification (or Registration) Service

Appoint The U.S. Agent	Establishment registration	Labeler company registration	OTC / Drug notification

Key Stage of OTC / Drug Notification (or Registration)

We provide comprehensive drug establishment registration and product listing services in accordance with U.S. FDA regulations, along with a range of additional regulatory support. Our services include preparing and reviewing required documentation, coordinating necessary laboratory testing, and assisting with U.S. Agent requirements, as well as providing timely updates on the registration process.

Our team supports drug registration applicants and registrants in fulfilling their regulatory obligations regarding the quality, safety, and efficacy of their products. Stay ahead of the increasingly stringent and rapidly evolving global pharmaceutical regulations with our expert guidance.

 

OTC / Drug Notification (or Registration) Service

While the OTC or drug notification (or registration) procedures can be found below, our services are not limited to these processes.

ㆍ      DUNS (Data Universal Numbering System) Number

ㆍ      FEI (FDA Establishment Identifier) Number

ㆍ      Drug Establishment Registration

ㆍ      Labeler Code

ㆍ      NDC (National Drug Code) code

ㆍ      Others: We offer customized solutions tailored to your target market's specific needs.

Certificate of OTC/Drug Notification (or Registration) Service

To strengthen the assurance that your products are successfully registered in the target market, we issue an exclusive KGMP certificate.

Remember that different regulations apply in each country.

Contact us today to discover how our drug ingredient and label compliance can benefit your business.

KGMP simplifies compliance with complex cosmetic regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final cosmetics.     

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of cosmetic products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our cosmetic regulation compliance services, please contact our expert directly.

Global expertise	Quality audit	Scientific expertise	Training	1:1 Consulting

Our professional, dynamic, and pragmatic team is ready to assist you with information and training.

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