Case Studies

March 8, 2021

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

Strengthening QPPV oversight through expert PSMF management for a global pharmaceutical company

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

Established a unifed, 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

Accelerating product approval by handling complex and voluminous medical writing projects

Our Medical Writing team helped the client in handling e-submission ready documents and accelerated the
March 8, 2021

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

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

Efficiently navigating the regulatory submission landscape

The Regulatory Affairs team at APCER Life sciences helped the client with streamlining the XEVMPD
March 8, 2021

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

March 8, 2021

Streamlining lifecycle management through proficient eCTD submission roadmap

APCER’s Pharmacovigilance (PV) team provided PV services right from set up, training and database usage.
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
March 8, 2021

Top 20 Pharmaceutical Innovator Raises Standards and Reduces Costs with Support from APCER Life Sciences

APCER Life Sciences as a specialized PV partner helped the company to harmonize all its
March 8, 2021

Growing Generics Company Teams with APCER Life Sciences to File Marketing Authorization Applications without Delay

Our team of Regulatory experts helped a generic pharma company seek approval in the UK
March 8, 2021

Innovative Biotechnology Company Relies on APCER Life Sciences to Manage Complex Safety Reporting in Oncology Trials

APCER Life Sciences supported an innovative biotechnology company in managing complex pharmacovigilance and regulatory requirements