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APCER Factsheet

Snapshot of end-to-end Safety services offered by APCER Life Sciences. We provide comprehensive drug safety/pharmacovigilance, medical information, medical writing, regulatory services, quality assurance and risk management programs to pharmaceutical and biotech companies globally.

Technology Enabled Integrated Pharmacovigilance Services

Our Integrated Pharmacovigilance operating model offers choice of best-in-class databases coupled with in-house scientific expertise to deliver high-quality compliance which is scalable, secure and technology-driven.

Clinical and Post-marketing Safety

APCER Life Sciences provides the right expertise and support required for coping up the ever-dynamic global regulatory requirements. We support the biopharma companies in managing their pharmacovigilance and drug safety activities right from the clinical phases of trials to the post-marketing and throughout the lifecycle. We work by building up an integrated safety program that responds rapidly to serious events, puts each case in context, and enables you to do risk-benefit assessment of your medicinal products.

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Our Services

Pharmacovigilance

APCER offers complete, cost-effective, and agile solutions to challenges in clinical safety and pharmacovigilance. We tailor our resources to meet your budget and fit your culture.

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Medical Information

APCER provides skilled healthcare professionals and a 24×7 Integrated Response Center to answer inquiries and disseminate information.

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Regulatory Affairs

APCER helps clients develop a filing strategy and perform regulatory activities worldwide throughout the lifespan of a product.

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Medical Writing

APCER’s team of medical writers helps life sciences companies craft medical, clinical and regulatory documents and stay in compliance throughout the product lifecycle.

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Medical Affairs

APCER has the medical resources needed to listen to the market, respond to opportunities, and communicate with timeliness and accuracy.

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Quality Assurance

APCER’s team of experienced quality auditors provide onsite and virtual GVP, GCP audits, GCLP audits and Gap Analysis services. Our end-to-end Quality Management System services ensure Anytime Inspection Readiness for our clients.

How can we work together for better health?

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    Testimonials

    • Medical Advisor, Medical Affairs,
      I must commend the organizational skill, the professionalism, the clarity, the expertise on subject matter, execution excellence that you and your team have exhibited in all of my projects where I had collaborated with you… It was a seamless, easy-going experience and I value and cherish every bit of it.
      Medical Advisor, Medical Affairs,
      A French Pharmaceutical Company
    • Global Clinical Leader, Thrombosis and Vascular Diseases,
      My experience with APCER has been excellent. Working with the team they were very helpful, knowledgeable, responsive and professional with all the work that was needed.
      Global Clinical Leader, Thrombosis and Vascular Diseases,
      A German biopharma company
    • Associate Submission Medical Writer
      APCER demonstrated extreme flexibility accommodating these changes and a number of last-minute changes that 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 German biopharma 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