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Safety

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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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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Regulatory Affairs

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

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Technology

APCER offers a variety of hosted environments for safety, medical, and regulatory operations at a fraction of the cost of in-house systems.

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How can we work together for better health?

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Testimonials

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

We are grateful to APCER’s whole hearted efforts in delivering submission ready documents & IB’s that lead to spectacular results. Our relationship with APCER has helped us redefine our Safety and medical information setup.

– Global PV Head, US-based pharmaceutical company

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

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

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

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