Ensure your product labeling meets every regulatory, linguistic, and formatting requirement—before it reaches the market.

Label & Insert Drafting

• Creation of compliant labels, patient inserts, and packaging artwork based on product type, therapeutic area, and regulatory classification.

• Integration of required elements such as dosage instructions, warnings, storage conditions, and manufacturer details.

• Alignment with international standards (ICH, WHO) and local agency-specific formatting rules.

Language & Localization Compliance

• Translation and adaptation of labeling content into Spanish and Portuguese, ensuring linguistic accuracy and cultural relevance.

• Review of terminology to meet country-specific medical and legal expectations.

• Support for bilingual packaging where required by regional regulations.

Regulatory Review & Validation

• Cross-checking of labeling content against approved product information, registration dossiers, and regulatory guidelines.

• Identification and correction of discrepancies, omissions, or formatting issues that could trigger regulatory rejection.

• Preparation of labeling components for inclusion in CTD/eCTD submissions.

Lifecycle Management & Updates

• Support for post-approval labeling changes, including safety updates, formulation modifications, and branding revisions.

• Coordination with regulatory authorities to ensure timely approval of updated packaging materials.

• Maintenance of version control and documentation traceability for audits and inspections.