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Drug Labeling Compliance is an important aspect of Regulatory Labeling

Product labeling and packaging artwork are crucial and integral part of product lifecycle during both stages of regulatory value chain i.e pre & post approval. Pharma labels and pack artworks have to be compliant as per regulations and applicable guidelines. These also communicate the important drug safety information to consumers. Guidelines and requirements for product labels and artwork ensure that patients as well as consumers remain informed of the safety information to mitigate any risks. Therefore, it is important to have processes in place that meticulously review artwork.

The product labeling and artwork review portfolio at DDReg covers all key review & change procedures effectively for a range of pharmaceutical products including small molecules, biomolecules, consumer healthcare products,medical devices and more. With provisions for country-specific labeling, label & artwork harmonization and translation management services, our dedicated team effectively manages product label mock-ups and artworks. From artwork development of primary, secondary & tertiary packs, to authoring & compilation of Summary of Product Characteristics (SPCs), Product Information Leaflets (PILs), Company Core Data Sheets (CCDS), carrying out structured product labeling (SPL) and labeling/artwork review procedures, , we ensure we are compliant with international standards and agency requirements. Our labeling & artwork management portfolio also includes claims, claim substantiation and regulatory review of products and our automated in-house artwork management tool reduces time in artwork and product label review to support and deliver rapid artwork management services.

Our regulatory labeling services include:

label

Product Labeling

Product labeling is intended to accurately communicate product information to healthcare...

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statements

Claim Substantiation

Claims are statements that represent pharmaceutical product’s content, information...

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artwork

Review Artwork

The label of a pharmaceutical product effectively communicates its information to the consumer...

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product

Structured Product Labeling

Structured Product Labeling (SPL) is a document markup standard approved by Health...

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Basics of regulatory product labeling

Regulatory labeling services play an important role in the pharmaceutical industry as they ensure that product labels meet the stringent regulatory standards. These services are essential to guarantee regulatory compliance with the complex and ever-evolving regulatory landscape that governs pharmaceutical and allied products. Regulatory labeling services encompass a comprehensive range of activities that are aimed at developing, reviewing, and updating pharmaceutical product labels that align with global regulations.

Effective regulatory labeling involves meticulous attention to detail to meet the specific requirements that are established by global regulatory authorities. DDReg’s regulatory labeling services are provided by dedicated regulatory experts who have experience in navigating the intricate and complex web of regulations to ensure pharmaceutical product labels are accurate, informative, and compliant with the most recent and updated guidelines. The team of regulatory experts, medical writers, and designers work synergistically to develop pharmaceutical regulatory labeling that not only conveys essential information about the product but also adheres to the stringent regulatory guidelines. Indeed, “regulatory labeling” underscores the critical nature of compliance with regulations that govern the pharmaceutical industry. DDReg’s has supported various pharmaceutical companies by providing comprehensive regulatory labeling services in streamlining their processes, reducing risk of regulatory non-compliance, and enhancing patient safety.

Services for regulatory labeling are indispensable for pharmaceutical companies that are looking to navigate the complex and dynamic regulatory environment. By focusing on regulatory compliance, DDReg’s services for regulatory labeling ensure that product labels meet the highest standards set by authorities worldwide. The meticulous attention to detail in regulatory labeling services is essential in safeguarding public health while maintaining the integrity of the pharmaceutical industry.

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