The quality of ICSR case processing impacts the risk–benefit profile and safe usage of the medicinal product

With the changing landscape of product types and regulatory requirements, the quality of case processing of the information received from various sources such as clinical trial information, spontaneous, literature, legal, social media, regulatory authority, license partner cases are crucial for the analysis of risk-benefit profile and the safe and effective use of the product.

APCER’s processes and systems help in:

• identifying the adverse drug reactions,
• interpreting the safety information,
• medical assessment,
• following-up for the missing information, and
• reporting within the stipulated regulatory timelines.

As an end-to-end pharmacovigilance service provider, we have the expertise in monitoring the regulatory landscape. We have the systems in place to continually assess the impact of changing regulations on existing processes to ensure regulatory compliance and inspection readiness.

Our expertise across product types includes:

• Drugs
• Vaccines
• Biologics
• Biosimilars
• Cell and gene therapy products/Advanced therapy medicinal products
• Medical Devices
• Combination products

Integrated Pharmacovigilance Services

Our pharmacovigilance operating model offers the choice of best-in-class databases coupled with in-house scientific expertise to deliver high-quality compliance, which is scalable, secure, and technology-driven.

As a part of our approach, our customers will choose the safety database (Argus or ARISg), which integrates best with their preferences. Both the safety platforms that APCER offers are backed by robust validation, assured infrastructure, certifications, security, and quality.