Case Studies

June 17, 2024

Risk Management Services

Identifying and managing safety concerns, implementing risk minimization measures (RMMs),
September 21, 2023

Ensuring EU-MDR Compliance

Medical device companies would need robust and effective strategies to
June 20, 2022

Clinical and Post-marketing Safety Services

APCER Life Sciences provides the right expertise and support required
June 16, 2022

Technology Enabled Integrated Pharmacovigilance Services

Our Integrated Pharmacovigilance operating model offers choice of best-in-class databases
April 23, 2021

Regulatory Services in the European Union

Rapidly changing regulations in the European Union are making regulatory
April 23, 2021

Pharmacovigilance Services in the European Union

The EU and UK regions have stringent Pharmacovigilance and regulatory
January 10, 2021

Quality Assurance services

Our team of experienced auditors help the bio-pharma companies achieve
January 10, 2021

Medical Writing Services

Our team of efficient and experienced medical writers support the
January 10, 2021

The Need for Vigilance

APCER Life Sciences provides the expertise and support required for
January 10, 2021

Post Marketing Safety Services

APCER Life Sciences provides the expertise, robust processes and infrastructure

Suggested Content

December 19, 2024

Change of Ownership – Global Regulatory Framework

December 19, 2024

Named Patient Programme: Early Access to Unapproved Medicines

November 5, 2024

Navigating FDA Type B Meetings : Harnessing Collaboration for Success

Navigating FDA Type B Meetings: Case Study Overview APCER Life

Testimonials

  • Medical Advisor, Medical Affairs
    I must commend the organizational skill, the professionalism, the clarity, the expertise on subject matter, execution excellence that APCER has exhibited in all my projects where I had collaborated…
    Medical Advisor, Medical Affairs
    A leading bio-pharma company
  • Global Clinical Leader
    My experience with APCER has been excellent. The team was very helpful, knowledgeable, responsive and professional with all the work that was needed.
    Global Clinical Leader
    A leading pharmaceutical company
  • Associate Submission Medical Writer
    APCER demonstrated extreme flexibility accommodating changes, and a number of last-minute changes were implemented quickly and correctly. I also appreciate the flexible communication during my workday, given the time zone differences between the APCER writers and myself.
    Associate Submission Medical Writer
    A leading bio-pharma company
  • Medical Director
    APCER’s speed, responsiveness and flexibility to meet our safety needs is something we have always valued. APCER has helped harmonize our global pharmacovigilance operations and made us compliant with ever changing regulations.
    Medical Director
    US-based specialty pharmaceutical company
  • QPPV and Pharmacovigilance Head
    The audit was carried out professionally and objectively. The scope of the audit was relevant and appropriate, and time efficient. The discussions during the audit were constructive and recommendations where helpful and appropriate. The team members involved in the audit had a positive experience and were made to feel at ease by the auditors.
    QPPV and Pharmacovigilance Head
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company
  • Head, Clinical Trial Transparency
    APCER’s invaluable support with Clinical trial disclosure deadlines helped us in timely submissions of periodic reports.
    Head, Clinical Trial Transparency
    Top 10 pharmaceutical company with operations in the EU and US
  • AVP, Pharmacovigilance
    We appreciate APCER for its efficiency in responding to matters that they get even at the eleventh hour. Working with APCER has made compliance a lot easier.
    AVP, Pharmacovigilance
    US-based pharmaceutical company
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company

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