Pharmacovigilance

April 21, 2022
pharmacovigilance services

Scaling up to address safety challenges for an Oncology product

APCER life sciences through its oncology expertise helped the pharma company manage its pharmacovigilance activites
March 8, 2021
pharmacovigilance consulting services

End-to-end pharmacovigilance support for a UK-based pharmaceutical company

APCER’s Pharmacovigilance (PV) team supported a client’s expansion into new markets by setting up a
March 8, 2021

Setting up Agile PV operations for a US based Pharma company

APCER’s Pharmacovigilance (PV) team helped a biotech pharmaceutical company with set up, training and database
March 8, 2021

Enabling compliance through strong PSMF management & QPPV oversight

APCER helped a leading generics company to streamline its PV related processes within 30 days.
March 8, 2021

Established a unified, global PV system for a pharma company after multiple M&A

We helped a large pharmaceutical company successfully transition its pharmacovigilance (PV) processes and helped establish
March 8, 2021
end to end pharmacovigilance

Enabling global expansion by establishing an integrated PV system

APCER helped a global pharmaceutical company in establishing a collaborative global pharmacovigilance (PV) governance model;
March 8, 2021

Active remediation measures help mitigate major safety findings

APCER Life Sciences supported one of the biopharma companies in assessing the effectiveness and setting
March 8, 2021

Efficient Risk Management Support for Marketing Authorization Applications in LATAM Region for a Leading Pharma Company

APCER Life Sciences supported a leading generic pharma company with managing the EU RMP requirements
March 8, 2021

Inspection Readiness: Supporting the pharma company in ensuring regulatory compliance with highest standards

Read how our Quality Assurance team helped a pharma company successfully host the USFDA inspection
March 8, 2021

GCP Audits in EU requiring local language competency for a biopharma company

We helped a biopharma company to set up end-to-end Quality Management System (QMS) and successfully
March 8, 2021

Significance of Medical Monitoring in smooth progression of clinical trials

APCER Life Sciences helped develop the strategy and provided medical monitoring services that accelerated the
March 8, 2021

Bridging the gaps and inconsistencies within CT program through an expert overlay of medical monitors

Our medical monitoring team with experience and expertise in early clinical development stages provided oversight
January 12, 2021

Importance of Engaging a Safety Partner Early in the Drug Life Cycle

Ms. Jeanne Schow, Vice President & US Head of Business Development talks the key benefits
January 10, 2021

Risk minimisation measures: Tracking and effectiveness assessment

January 6, 2021

RMP Team Collaboration Across Functions

January 6, 2021

aRMM Implementation Strategy

January 6, 2021

Identification of risks and determination of aRRM requirement