End-to-end Pharmacovigilance Services

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Benefits of Outsourcing to a Specialized Safety Partner

Your Full Service Pharmacovigilance Partner

ICSR Case Processing
Quality of ICSR case processing impacts the risk–benefit ratio and safe usage of the medicinal product.
Literature Search
Global and local literature monitoring for adverse event identification across the drug life cycle.
Aggregate Reporting
Periodic aggregate reporting of risk–benefit profile to regulatory authorities throughout the drug life cycle.
Signal Management
Capturing signals from varied sources to assure safety of the product to regulatory authorities.
PSMF
Preparation and maintenance of comprehensive documentation on pharmacovigilance systems for all marketed products.
QPPV
The QPPV office oversees implementation, provides direct oversight, and maintains end-to-end pharmacovigilance systems for the sponsor.

Enabled by Technology-driven Customized Solutions

Integrated PV services provide a holistic safety approach through seamless information and data flow with well-defined metrics and real-time data analytics, including:

APCER: Your Trusted Pharmacovigilance Partner

800+

full-time employees

90%

of employees are HCPs

100+

physicians on staff

Safety reporting in

100+ countries

Experience in supporting

80+ regulatory inspections

Compliant to Quality and Data Privacy Industry Standards

ISO 9001: 2015

Quality Management System certification (QMS)

The globally recognized and accepted standard for QMS validates our unwavering commitment to excellence in quality.

ISO 27001: 2013

Information Security Management System Certification (ISMS)

The gold standard for ISMS reiterates our long-standing commitment to adopt the best security practices for employees and customers.

ISO/IEC 27701:2019

Certification for Privacy Information Management System (PIMS)

The accreditation endorses our perpetual pursuit to achieve excellence in data privacy and providing enhanced assurance to our clients.