DDReg Pharma

Labelling Services

With experts having prior experience of working on CHC products, we provide updated labelling and compliance packages, that assist in the development of Product Labelling, Artwork Review & Compliance and Claim Substantiation.

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.
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Our regulatory labeling services include:

Product Labelling

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

Structured Product Labeling

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

Review Artwork

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

Claim Substantiation

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

Core Company Data Sheets

Company Core Data Sheet (CCDS) Represents company position based on the data and developed for...

Patient Information Leaflet

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for...

Core Company Data Sheets

Company Core Data Sheet (CCDS) Represents company position based on the data and developed for...

Patient Information Leaflet

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for...

SPC & Prescribing Information

The product information in Summary of Product Characteristics (SPC) and Package Insert (PI) have major...

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