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Pharmaceutical Labelling Services

What is Pharmaceutical Labelling?

Pharmaceutical labelling refers to the creation, review, and management of all written, printed, or graphic information that accompanies a medicinal product. This includes everything from the prescribing information (PI) and package inserts to carton labels, leaflets, and summary of product characteristics (SmPC).

Accurate and compliant labelling ensures patient safety, regulatory compliance, and market success — across both clinical development and post-marketing phases.

Our Labelling Services

We offer comprehensive labelling services across the product lifecycle — from clinical trials to global product launches and maintenance.

1. Label Content Development & Updates

  • Drafting and maintenance of:

    • Prescribing Information (PI)

    • Patient Information Leaflets (PIL)

    • Summary of Product Characteristics (SmPC)

  • Label updates based on safety signals, regulatory changes, or product variations

2. Label Review & Compliance Checks

  • Regulatory, medical, and linguistic review of all labelling materials

  • Alignment with local and global regulations (FDA, EMA, MHRA, PMDA)

  • Cross-functional QC with safety, clinical, and regulatory teams

3. Labeling Artwork & Packaging Support

  • Coordination with design teams for artwork creation

  • Proofing and compliance validation (barcodes, QR codes, branding)

  • Labeling version control and artwork tracking systems

4. Global Labelling Management

  • Centralized management of global core data sheets (CCDS)

  • Local label adaptation and translation support for international markets

  • End-to-end change control for label variations

5. Labelling in Clinical Trials

  • Labelling content for investigational products (IP)

  • IMP packaging and distribution compliance (Annex VI, GCP)

  • Support for blinded and open-label studies

6. Labeling Regulatory Submissions

  • Compilation and submission of labelling sections in:

    • NDA/BLA/MAA submissions

    • Variation applications

    • Renewal dossiers

  • Label negotiation with regulatory authorities

🌐 Regulatory Expertise Across Regions

We provide region-specific labelling support in accordance with:

  • FDA (USA) – SPL, Drug Facts, Package Inserts

  • EMA (EU) – SmPC, PIL, Blue Box requirements

  • MHRA (UK) – ePI, labelling guidance post-Brexit

  • Health Canada, TGA, PMDA, and other national authorities

⚙️ Why Choose Us?

  • ✔️ End-to-end labelling support from development to commercialization

  • ✔️ Expert knowledge of global and local labelling regulations

  • ✔️ Risk-based approach to labelling changes and lifecycle management

  • ✔️ Cross-functional collaboration with regulatory, PV, and QA teams

  • ✔️ Digital labelling and ePI (electronic product information) capabilities

📞 Get in Touch

Ensure your product labelling is accurate, compliant, and ready for market.
Reach out today for a custom solution tailored to your regulatory needs.

📧 Email: [company@shudarsana.com]

🔗 Related Services

 

  • Regulatory Affairs

  • Clinical Documentation

  • Pharmacovigilance

  • Medical Writing

  • Quality Assurance & Regulatory Compliance

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