Artwork & Labeling Services - Techsol Life Sciences

Regulatory Operations Services

Artwork & Labeling

Delivering End-to-End Global Labeling Compliance for Life Sciences Products

In the global life sciences industry, labeling is a critical communication tool that directly impacts patient safety, product usability, market access, and compliance. With constant changes in regulatory expectations and country-specific formatting rules, the challenge for pharmaceutical, biotechnology, and medical device companies lies in maintaining accurate, compliant, and up-to-date product labeling throughout the entire product lifecycle.

At Techsol Life Sciences, we offer comprehensive Artwork and Labeling Services designed to help companies manage and maintain compliant labeling and packaging for their global product portfolios. From the initial creation of core labeling documents to region-specific adaptation, artwork generation, regulatory submission support, and lifecycle management, our team ensures your product labeling meets all applicable regulatory, linguistic, and formatting standards.

Navigating the Global Labeling Landscape

Regulatory authorities such as the FDA (USA), EMA (EU), MHRA (UK), Health Canada, and other agencies have specific and detailed requirements for product labeling, including:

Inconsistent or non-compliant labeling can result in:

Techsol bridges the gap between regulatory strategy and operational execution with a labeling team that understands both content and compliance.

Our Comprehensive Labeling Services Include:

Global Labeling Document Development

We support the creation, maintenance, and country-specific adaptation of regulatory labeling documents across all major regions and product types.

CCDS (Company Core Data Sheet)

Development and ongoing maintenance of global reference labeling to align product information across multiple markets. This includes establishing a harmonized core for safety, efficacy, and dosing information.

USPI (U.S. Prescribing Information)

Authoring and updating structured product labeling content in accordance with FDA labeling format requirements (PLR/SPL), including Highlights of Prescribing Information, Full Prescribing Information (FPI), and patient information.

SmPC (Summary of Product Characteristics)

Development of EMA-compliant SmPCs following the latest QRD template, adapted for Centralized, Decentralized, or National Procedures.

Instructions for Use (IFU)

Creation and formatting of device and combination product IFUs that meet both U.S. and EU expectations under FDA 21 CFR 801 and EU MDR/IVDR, including usability, pictograms, readability testing, and localization.

Regulatory-Compliant Artwork Design, Proofreading, and Review

We offer full-scope support for the creation, update, and validation of primary and secondary packaging components:

Our Capabilities Include

Design and layout of packaging elements such as:

Cartons, vials, blisters, labels, and leaflets
Shippers and overwraps

Integration of safety elements like:

Tamper-evident seals, unique device identifiers (UDIs), barcodes, and serialization data

Dual-proofreading of text and visual content for:

Regulatory accuracy
Typographical consistency
Language correctness (including country-specific translations)
Compliance with QRD (EU) and SPL (FDA) standards

Tools Used

Adobe Creative Suite (Illustrator, InDesign, Acrobat)
Global labeling platforms (Veeva Vault RIM, GLAMS, or client systems)
Automated and manual proofreading systems

Labeling Strategy and Submission Support

Our regulatory affairs team works alongside our labeling group to guide clients through global submission requirements involving labeling content and format.

Submission Support Includes:

FDA Structured Product Labeling (SPL):

Creation of XML files
Validation using FDA-authorized software
Submission via the Electronic Submissions Gateway (ESG)

EMA QRD Compliance:

Application of the latest EU QRD templates
Support for Annexes (Annex I – III) and multilingual labeling
Country-specific product information formatting

Regulatory Justifications & Lifecycle Submissions:

Labeling change justifications for supplements and variations
Response documents to health authority queries
Supporting documentation for renewals, PBRERs, and PSURs

Labeling Lifecycle Management & Change Control

Post-approval label changes are common due to evolving safety information, new indications, or regulatory mandates. We offer full lifecycle support to ensure labeling remains current, accurate, and harmonized globally.

Lifecycle Labeling Services Include:

Our Expertise

Our team comprises regulatory professionals, technical writers, labeling specialists, and graphic designers who bring in-depth knowledge of both science and compliance. This unique blend ensures that your labeling is not only accurate but also regulatory-ready for global submissions.

We support labeling activities for products being submitted or marketed in:

United States (FDA)
European Union (EMA, national authorities)
Canada (Health Canada)
Australia (TGA)
Japan (PMDA)
Middle East, ASEAN, and Latin American countries

We follow robust SOPs, controlled workflows, and multi-tiered quality checks to ensure that every label and artwork component meets regulatory and internal client standards before approval.

We leverage publishing platforms, labeling systems, and collaborative project tools to:

Ensure transparency, tracking, and audit-readiness
Seamlessly integrate with your existing Regulatory Information Management (RIM) or document management system