Together for minimizing risks

Pharmacovigilance Services

The essential objective of any regulator governing drug development and commercialization is to ensure public safety. The underlying objective of pharmacovigilance is to promote safe and effective use of drug products. The successful development of any product depends on various factors, such as safety and efficacy portfolio, quality of clinical data, appropriate regulatory strategies, and timely submission at each step of approval. After the drug is approved, appropriate risk mitigation strategies and pharmacovigilance processes must be in place to comply with the applicable regional and global regulatory requirements otherwise there might be serious consequences of non-compliance. Therefore, partnering with the companies having strong expertise in handling global and complex regulatory requirements will help ensure inspection readiness and safe and effective use of therapeutic products.

ICSR Case Processing

Quality of ICSR case processing impacts the risk–benefit ratio and safe usage of the medicinal product.

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Literature Search

Global and local literature monitoring for adverse event identification across the drug life cycle.

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Aggregate Reporting

Periodic aggregate reporting of risk–benefit profile to regulatory authorities throughout the drug life cycle.

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Risk Management

Developing an efficient risk management system for proactive risk assessment and continued safety surveillance.

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end to end pharmacovigilance

Signal Management

Capturing signals from varied sources to assure safety of the product to regulatory authorities.

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QPPV

The QPPV office oversees implementation, provides direct oversight, and maintains end-to-end pharmacovigilance systems for the sponsor.

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PSMF

Preparation and maintenance of comprehensive documentation on pharmacovigilance systems for all marketed products.

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Pharmacovigilance Brochures

The Need for Vigilance
A Model for Clinical Safety
Integrated Pharmacovigilance

The APCER Advantage

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Domain Expertise
  • 100+ physicians, 90% healthcare professionals supporting drug safety and Pharmacovigilance
  • Experience and expertise in different product types including Drugs, Vaccines, Biologics, Biosimilars, Cell and Gene Therapy products / Advanced Therapy Medicinal Products, Medical Devices, and Combination products
  • Medical and scientific writing to support global product approval and post marketing requirements
pharmacovigilance services
Client Focus
  • Scalable and flexible operating models
  • Strong governance with collaborative approach
  • Outcome-driven engagements
  • End-to-end Pharmacovigilance, Medical Information, Regulatory Affairs, Quality Assurance and Medical Writing activities throughout the Product lifecycle
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Global Presence
  • Presence in US, UK, Europe, and Asia
  • Safety reporting capabilities in 100+ countries
  • Medical Information coverage in 50+ countries and 30+ languages, scalable to 100+ languages
  • Developing and contributing to regulatory strategies, to maintain global regulatory compliance across the product life cycle
pharmacovigilance consulting services
Quality and Compliance
  • Extensive experience in supporting successful Regulatory Inspections
  • ISO accreditations received:
    • ISO 9001:2015 (QMS)
    • ISO 27001:2013 (ISMS)
    • ISO 27701:2019 (PIMS)

How can we work together for better health?

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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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