Case Studies

September 21, 2023

Ensuring EU-MDR Compliance

Medical device companies would need robust and effective strategies to comply with the ever-changing regulatory
June 20, 2022

Clinical and Post-marketing Safety Services

APCER Life Sciences provides the right expertise and support required for coping up the ever-dynamic
June 16, 2022

Technology Enabled Integrated Pharmacovigilance Services

Our Integrated Pharmacovigilance operating model offers choice of best-in-class databases coupled with in-house scientific expertise
April 23, 2021

Regulatory Services in the European Union

Rapidly changing regulations in the European Union are making regulatory compliance even more stringent. As
April 23, 2021

Pharmacovigilance Services in the European Union

The EU and UK regions have stringent Pharmacovigilance and regulatory requirements such as electronic and
January 10, 2021

Virtual Auditing Services

Our team of experienced auditors help the bio-pharma companies achieve process excellence and regulatory compliance.
January 10, 2021

Medical Writing Services

Our team of efficient and experienced medical writers support the biopharma companies in delivering high
January 10, 2021

The Need for Vigilance

APCER Life Sciences provides the expertise and support required for coping up the ever-dynamic global
January 10, 2021

Post Marketing Safety Services

APCER Life Sciences provides the expertise, robust processes and infrastructure required for global pharmacovigilance. Our
January 10, 2021

Clinical Safety Services

APCER Life Sciences works together with your team and research partners to create a centralized

Suggested Content

April 30, 2024

Compiling Large Volumes of Real World Data and Creating a Report with Appendices for a Global Client

Our Medical Writing (MW) team demonstrated exceptional expertise and dedication by preparing a complex, comprehensive,
April 5, 2024

Leveraging Aggregate Reporting for EU-MDR Compliance and Proactive Risk Management for a Medical Device company

A leading device manufacturer faced challenges complying with complex device regulations and thus struggled to
February 19, 2024

GAP analysis and CER assessment for CE certification: A simple path to EU-MDR compliance

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

How can we work together for better health?

    Please note that by submitting this form, you consent to your personal data being processed in alignment with our Privacy Policy. APCER is committed to ensuring the security and protection of your personal information. Your personal data will be processed for purpose of facilitating your request and may be used for sending you additional marketing and business development-related information about APCER Life Sciences, its affiliates and our services. You can withdraw your consent by writing to us at DPO@apcerls.com.