Pharmaceutical

PHARMACEUTICAL LABELING

The pharmaceutical industry is responding to expiring drug patents and increasing competition from generics by focusing on the introduction of both new products and multiple variants of existing products, into many markets.

Labeling, packaging and artwork design and production have proven a challenging operational activity. Ever-changing regulatory statements, language translations and patient-led design considerations can all impact your timescales for producing high quality drug labels and packaging, and thereby introducing risk and cost for new products.

If you do not identify and resolve errors in product labeling and packaging, any resulting product recalls will not only have a financial implication, but also a significant impact on the reputation and trust the brand has with patients, prescribers, regulators and other stakeholders.

Our label and artwork management products are designed to enable error-free, high quality packaging and labels to be produced efficiently; regardless of whether you’re a multi-national organization with several thousand products, or a small company with resource or expertise constraints.

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PRISYM 360

This solution provides organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.

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SERVICES

Our team of in-house compliance and validation subject matter experts and professional services and support teams can support you from implementation through beyond delivery.

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PHARMACEUTICAL LABELING RESOURCES