Case Studies

June 27, 2024

Re-defining Brand Value: The Role of Scientific Communication in Pharmaceutical Success

A global pharmaceutical company leveraged our Scientific Writing team’s expertise to reposition one of its
April 30, 2024
end to end mi services

Compiling Large Volumes of Real World Data and Creating a Report with Appendices for a Global Client

Our Medical Writing (MW) team demonstrated exceptional expertise and dedication by preparing a complex, comprehensive,
April 5, 2024
medical Inquiries

Leveraging Aggregate Reporting for EU-MDR Compliance and Proactive Risk Management for a Medical Device company

A leading device manufacturer faced challenges complying with complex device regulations and thus struggled to
May 3, 2023

Partnering for CMC Writing in New Drug Application

CMC writing is a standardized scientific and technical writing process to develop the documentation needed
March 6, 2023

Establishing a regulatory roadmap for post-approval lifecycle management

A drug product transitions from different phases throughout its life cycle. The sponsors/applicants may outsource
September 30, 2022

Managing Seamless Transition and Establishing KPI driven Operations

Managing Medical information (MI) services in-house is a major challenge for any pharmaceutical company. Read
September 2, 2022

Updating a complex Investigator Brochure (IB) for an oncology product within demanding timelines

Our Medical Writing team helped the client in updating and submitting high-quality investigator brochure- a
May 18, 2022

Standardization and publication of evidence-based local recommendations for pharmacological treatment of pain

We supported a large biopharma company in preparing manuscript/narrative review articles and leveraged our Medical
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

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
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

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

Read how our Quality Assurance team helped a pharma company successfully host the USFDA inspection
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