Drug Ingredient & Labeling

    

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Drug Ingredient & Labeling

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.

Drug Ingredient and Label Compliance: Essential Insights for Your Business

Understanding pharmaceutical ingredients and labeling regulations is essential for manufacturers and distributors. Active ingredients and excipients must comply with approval requirements in target markets, while labels must accurately convey efficacy, usage, composition, and safety. (QSR).

Clear and compliant labeling prevents misleading claims and ensures consumer safety. Failure to meet regulatory standards can result in fines, legal issues, reputational damage, recalls, and market delays.

KGMP Drug Ingredient & Label Review Service

Ingredient assessment	Mandatory requirements	Label format	Marketing claims

Key Stage of Ingredient & Label Review

We provide pharmaceutical ingredients and labeling review services to ensure compliance with regulatory requirements, focusing on ingredient approval criteria and labeling accuracy to prevent regulatory violations.

Our team cross-references your ingredients and labels with applicable regulations, official guidance, and enforcement actions from relevant authorities in your target market. With our expert reviews, you can streamline regulatory approvals, minimize compliance risks, and prevent costly delays or import restrictions.

 

Drug Ingredients Review Includes:

ㆍ      INCI name or ICID name CAS number or Pharmacopeia (e.g., USP, EP, UP, KP, etc.)

ㆍ      Conditions for the use of approved active ingredients

ㆍ      Inactive ingredient regulation

 

Drug Label Review Includes:

ㆍ      Format, font size, the order and place of declarations

ㆍ      Mandatory requirements such as identity, net contents, drug facts, active ingredients and purpose, inactive ingredients, direction, cautions, business information, country of origin, expiration date, batch number, and etc.

ㆍ      Marketing claims such as approved purpose or claims, and etc.

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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