Case Studies

October 7, 2024

Collaborative Expertise Secures Successful FDA Meeting for Phase 2b Oncology Trial

Securing Type C meeting with FDA for Oncology Trial: Case
September 11, 2024

Successfully Enabled CTD Modules Preparation within Stringent Timelines

Submission of Common Technical Document Modules: Case Study Overview A
August 30, 2024

Ensuring Regulatory Compliance: Managing Global and Local Literature Surveillance for Drugs and Medical Devices for a Leading Pharmaceutical Company

Managing Global and Local Literature Surveillance: Case Study Overview Client
July 30, 2024

Successful Project Transition Through Proactive Planning and Flawless Execution for Aggressive Go-Live for a Leading Biotech Company

With an aggressive go-live target and a need for experienced
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
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
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
May 3, 2023

Partnering for CMC Writing in New Drug Application

CMC writing is a standardized scientific and technical writing process
March 6, 2023

Establishing a regulatory roadmap for post-approval lifecycle management

A drug product transitions from different phases throughout its life
September 30, 2022

Managing Seamless Transition and Establishing KPI driven Operations

Managing Medical information (MI) services in-house is a major challenge
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
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
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
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
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
March 8, 2021

Enabling compliance through strong PSMF management & QPPV oversight

APCER helped a leading generics company to streamline its PV
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
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
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
March 8, 2021

Active remediation measures help mitigate major safety findings

APCER Life Sciences supported one of the biopharma companies in
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
March 8, 2021

Efficiently navigating the regulatory submission landscape

The Regulatory Affairs team at APCER Life sciences helped the
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
March 8, 2021

Streamlining lifecycle management through proficient eCTD submission roadmap

APCER’s Pharmacovigilance (PV) team provided PV services right from set
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
March 8, 2021

Significance of Medical Monitoring in smooth progression of clinical trials

APCER Life Sciences helped develop the strategy and provided medical
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