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Case Studies
October 7, 2024
October 7, 2024
Collaborative Expertise Secures Successful FDA Meeting for Phase 2b Oncology Trial
Securing Type C meeting with FDA for Oncology Trial: Case
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September 11, 2024
September 11, 2024
Successfully Enabled CTD Modules Preparation within Stringent Timelines
Submission of Common Technical Document Modules: Case Study Overview A
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August 30, 2024
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
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
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June 27, 2024
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
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April 30, 2024
April 30, 2024
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
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April 5, 2024
April 5, 2024
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
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May 3, 2023
May 3, 2023
Partnering for CMC Writing in New Drug Application
CMC writing is a standardized scientific and technical writing process
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March 6, 2023
March 6, 2023
Establishing a regulatory roadmap for post-approval lifecycle management
A drug product transitions from different phases throughout its life
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September 30, 2022
September 30, 2022
Managing Seamless Transition and Establishing KPI driven Operations
Managing Medical information (MI) services in-house is a major challenge
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September 2, 2022
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
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May 18, 2022
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
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April 21, 2022
April 21, 2022
Scaling up to address safety challenges for an Oncology product
APCER life sciences through its oncology expertise helped the pharma
…
March 8, 2021
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
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March 8, 2021
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
March 8, 2021
Enabling compliance through strong PSMF management & QPPV oversight
APCER helped a leading generics company to streamline its PV
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March 8, 2021
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
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March 8, 2021
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
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March 8, 2021
March 8, 2021
Enabling global expansion by establishing an integrated PV system
APCER helped a global pharmaceutical company in establishing a collaborative
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March 8, 2021
March 8, 2021
Active remediation measures help mitigate major safety findings
APCER Life Sciences supported one of the biopharma companies in
…
March 8, 2021
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
March 8, 2021
Efficiently navigating the regulatory submission landscape
The Regulatory Affairs team at APCER Life sciences helped the
…
March 8, 2021
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
March 8, 2021
Streamlining lifecycle management through proficient eCTD submission roadmap
APCER’s Pharmacovigilance (PV) team provided PV services right from set
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March 8, 2021
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
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March 8, 2021
March 8, 2021
Significance of Medical Monitoring in smooth progression of clinical trials
APCER Life Sciences helped develop the strategy and provided medical
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March 8, 2021
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
…
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