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December 2, 2020

Together for Reliable Communication

Medical Information

Regional regulatory requirements, privacy laws, diverse languages and the limited availability of trained staff have made it difficult to establish a well-equipped contact center to answer medical inquiries about the medicinal products. Healthcare professionals (HCPs) at APCER understand and appreciate the importance of providing a balanced response within a regulated environment, whether the inquiry comes from a physician, pharmacist, patient, caregiver, or pharmaceutical representative. Our team works closely with our clients so that their customers can make informed choices about their medicinal products.

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Integrated Response Center

24x7 Integrated Response Center offers end-to-end medical information services for different medicinal products, which can be customized based on customer requirements. APCER provides custom solutions to meet the specific needs of the medicinal products, local and global regulatory requirements.

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Specialized REMS Contact Center

Our Medical Information team can handle end-to-end activities for a specialized REMS contact center, including but not limited to support for general program inquiries, patient/physician/pharmacist enrollment/registration, and knowledge assessment.

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Together for Accurate and Reliable Medical Information

Our 24×7 medical information contact centers are equipped with state-of-the-art technology which offers customizable, multi-channel and multi-lingual support to biopharmaceutical and medical device companies worldwide. APCER provides you assurance that patients and healthcare professional needs are handled accurately, consistently and with the urgency you expect, and our processes are fully regulatory validated ensuring compliance.

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The APCER Advantage

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Domain Expertise
  • Highly experienced teams of industry / medical professionals cross trained in basic PV processes
  • Fully integrated & GAMP-5 validated technology platforms – IRMS, RingCentral, Chat systems
  • 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
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Client Focus
  • Dedicated and/or shared team models with ability to scale
  • Fully customizable AE, PQC, QA and Content Management Modules.
  • Specialized services for full support for REMS programs, patient support programs, post-authorization registries, and compassionate use programs.
  • Well-established processes for managing requests/inquiries coming from healthcare providers, patients/consumers, sales representatives, and online website submissions
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Global Presence
  • Integrated Response centers’ presence in US, Canada, and India with capability to manage overflows/spikes
  • Medical Information coverage in 50+ countries and 30+ languages, scalable to 100+ languages
  • 24x7x365 coverage to address different time zones
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Quality and Compliance
  • Extensive experience in supporting successful Regulatory Inspections
  • ISO accreditations received:
    1. ISO 9001:2015
    2. ISO 27701:2019
    3. ISO 27001:2022
  • Quality SLAs of 100% for critical fields and >99.6% for non-critical ones, with abandonment rates consistently below 5%.

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 APCER has exhibited in all my projects where I had collaborated…
    Medical Advisor, Medical Affairs
    A leading bio-pharma company
  • Global Clinical Leader
    My experience with APCER has been excellent. The team was very helpful, knowledgeable, responsive and professional with all the work that was needed.
    Global Clinical Leader
    A leading pharmaceutical company
  • Associate Submission Medical Writer
    APCER demonstrated extreme flexibility accommodating changes, and a number of last-minute changes 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 leading bio-pharma 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

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    February 19, 2024

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


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How can we work together for better health?

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    APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory and technology resources to ensure that patients receive the safest, most effective therapies possible.

    We are an ISO 9001:2015, ISO 27701:2019 and ISO 27001:2022 certified company.

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