APCER Life Sciences is a preferred Pharmacovigilance Partner for Pharmaceutical and Biotech companies looking for compliance and adverse event reporting solutions across the drug life cycle. Our ‘Patients First’ approach enables us to deliver end-to-end drug safety, medical information, medical writing, regulatory affairs, quality assurance and risk management services globally.

Our global team of healthcare professionals and physicians bring together medicinal, therapeutic and scientific expertise to biopharmaceutical companies developing safe drugs, vaccines and advanced therapies.

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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.

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Testimonials

  • 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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