Labeling Updates - Techsol Life Sciences

Life Cycle Management

Labeling Updates

Our Regulatory team will ensure that the all labeling changes whether prompted by new safety data, regulatory requests, or company-driven updates are accurately reflected, scientifically justified, and compliant with regional Health Authority guidelines.

Labeling updates (USPI, SmPC, PIL, CCDS)

At Techsol, we understand the critical importance of maintaining accurate and compliant product labeling throughout the product lifecycle. Our regulatory experts provide end-to-end support for the preparation, review, and submission of labeling updates to meet evolving regulatory requirements across global markets.

We manage a wide range of labeling documents, including:

Our Services Include:

Preparation and revision of core labelling documents including:

US Package Inserts (USPI)
Summary of Product Characteristics (SmPC)
Patient Information Leaflets (PIL)
Company Core Data Sheets (CCDS)

Benefits of Effective Labeling & Promotional Support

Ensures full compliance with applicable legal, regulatory, and industry standards
Minimizes risk of regulatory penalties, fines, and product recalls by providing accurate, and clear information
Prevents misleading, false, or deceptive claims in both labelling and promotional materials
Enhances transparency and truthful communication to protect consumer rights and safety
Facilitates regulatory inspections, audits, and documentation requirements with consistent product information
Supports traceability, accountability, and supply chain integrity through clear labelling and aligned promotional content
Promotes ethical marketing practices and adherence to corporate social responsibility guidelines
Reduces regulatory scrutiny by aligning promotional claims strictly with approved labelling and product data
Builds trust and credibility with regulators, consumers, and stakeholders through compliance and transparency
Helps maintain market access and competitive advantage by meeting evolving regulatory demands

Our Expertise and Value Proposition

Proven Global Regulatory Expertise: Over 500+ labeling submissions delivered, with in-depth knowledge of US FDA, EMA
Process Standardization and Best Practices: Well-defined workflows for labeling updates and change submissions minimize delays, regulatory risks, and ensure high-quality deliverables
Harmonized Global Labeling Strategy: Support for consistent labeling across global markets while meeting country-specific requirements and maintaining regulatory alignment
Agile Response to Regulatory Changes: Rapid integration of safety updates and urgent directives into USPI, SmPC, PIL, and CCDS documents to maintain market readiness
End-to-End Lifecycle Support: Comprehensive management from document drafting, version control, and cross-functional coordination to complete regulatory submission support