The Role of Regulatory Labeling

Regulatory labeling regulations play a crucial role in ensuring the safe and effective use of drug products by patients. However, compliance with these regulations can be complex, especially with the introduction of new requirements and updates.

Managing global and regional labeling in the life sciences industry presents a complex challenge. With guidance, mandates, and recommendations issued for various labeling aspects such as clinical information, dosage, warnings, adverse reactions, and therapeutic group classes, companies must navigate a complex landscape to ensure consistency and compliance across regions. This process is time-consuming and requires meticulous attention to detail to meet regulatory requirements effectively.

“Regulatory labeling is essential for ensuring compliance of drug products to be used safely and effectively by patients. Our team of highly qualified medical experts at Celegence provide end-to-end regulatory labeling information that helps ensure the most up-to-date information is expressed in the labeling documentation to patients and healthcare practitioners,” said Sonia Veluchamy, CEO of Celegence.

Celegence employs five key strategies to ensure regulatory labeling compliance:

1. Initial Assessment and Understanding of Regulations: An initial labeling assessment conducted by skilled Subject Matter Experts (SMEs) will determine your compliance needs, decode labeling regulations relevant to your drug product portfolio, and offer recommendations.
2. CCDS Management: Utilize a panel of experts to handle complex tasks like creating, updating, and maintaining Company Core Data Sheets (CCDS) to ensure consistency and compliance.
3. Regional Specific Regulation Guidance: Celegence’s team of experts to keep you informed about the latest regional specific and local regulation changes such as the US FDA’s Pregnancy Lactation Labeling Rule, EU’s Falsified Medicines Directive, and BREXIT impact analysis, to maintain compliance and due diligence.
4. Medical and Clinical Documentation: Celgence assists in creating background medical and clinical documentation, including medical writing, formatting, publishing, and submitting labeling variations to local authorities, ensuring compliance with ICH and country-specific requirements for Health Authority submissions.
5. Comprehensive Labeling Support: We provide end-to-end regulatory labeling services to build and maintain labeling information, including safety and efficacy details on country-specific labels, ensuring compliance and due diligence.

In a world where precision matters, Celegence stands as your partner, elevating regulatory excellence. Celegence, founded by Sonia Veluchamy, provides regulatory operations and assistance with Efficient MDR & IVDR Document Creation.

We can be reached at info@celegence.com or contact us online for more information.