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August 21, 2023

Together for Quality Excellence

Quality Assurance Services

An effective quality management system (QMS) is essential for marketing authorization holders (MAHs) to meet unannounced and stringent regulatory inspections. Besides increasing complexity of clinical development and pharmacovigilance (PV), the regulatory requirements of various health authorities are also constantly updating and getting specific. To have a compliant QMS, MAHs need to ensure a robust and effective audit program and maintain routine QMS activities.

APCER provides effective and efficient Quality Assurance (QA) services to ensure compliance to regulatory requirements and industry standards, resulting in safe and effective use of medicinal products. Through trained and experienced quality auditors specializing in PV and clinical domain, APCER can provide expertise and an anytime inspection-ready environment.

GCP, QA and Audit Support

  • Development and management of a risk-based audit program
  • Clinical trial audits, including investigator sites/facilities, trial master file (TMF) audits, and clinical study report (CSR) reviews
  • Vendor/service providers’ qualification/re-qualification audit
  • Clinical monitoring services
  • Pharmacokinetic (PK) and clinical data management
  • GCP standard operating procedure (SOP) management
  • Good clinical laboratory practice (GCLP) audits, including anti-drug antibody/neutralizing antibody (ADA/NAB) analysis data audit
  • Good Clinical Practices (GCP) standard operating procedure (SOP) management

GVP Quality Support

  • Support in setting up a QMS for PV system
  • Good pharmacovigilance practice (GVP) system audit
  • Process-focused audit, such as risk management plan (RMP)/additional risk minimization measure (aRMM), risk evaluation and mitigation strategies (REMS), and signal management
  • Safety management plan review
  • Pharmacovigilance documents review, such as pharmacovigilance system master file (PSMF) and PV agreements
  • Document management/governance
  • Document management, e.g., SharePoint site management
  • Business partner/affiliate audits
  • Vendor/service provider audits

Inspection Readiness

  • Gap analysis
  • Mock inspections
  • Anytime inspection readiness
  • Inspection/partner audit hosting
  • Anytime inspection-ready team

IT Quality Support Program

  • Onsite and virtual audit expertise
  • GxP assessments
  • Computerized system validation review in line with internationally recognized standards
  • Database implementation support

QMS Consulting

  • Trained and qualified full-time equivalent (FTE) QA resource with flexible working hour models
  • Preparation and maintenance of procedural documents
  • Corrective action and preventive action (CAPA) management and CAPA effectiveness check
  • Change management
  • Training management
  • Support in resolving inspection findings
  • QA staff augmentation services
  • QA project outsourcing

Certification Audits

  • ISO 9001, 27001, and 27701 readiness

Third-Party Audits

  • Partner/affiliate audit
  • Service provider audit

CAPA Management

  • Tracking of internal, external, and regulatory CAPAs on database/manual entry
  • CAPA effectiveness checks

Remote/Virtual Audits

  • Virtual interactive audits – driven through technology
  • Development of questionnaires for non-interactive audits

Quality Risk Management in Pharmacovigilance

In accordance with QRM principles, APCER takes a proactive approach to compliance across its service deliverables, which is depicted in the following figure:

Virtual Auditing Services

The pharmaceutical companies and regulatory authorities are adapting to the new ways of ensuring compliance from a drug safety and efficacy perspective. As a result, there is an increasing trend of conducting virtual audits and inspections in the new normal.

Together for Inspection Readiness

The APCER Advantage

pharmacovigilance companies in usa
Domain Expertise
  • 20+ qualified QA Professionals
  • Experience and expertise in various domains, such as GCP, GCLP, GVP, information security management system (ISMS), and ISO certifications
  • Trained QA professionals and International Registry for Certified Auditors (IRCA)-certified auditors
  • Transaction-based/FTE-based flexible working hour models
pharmacovigilance service providers in eu
Global Presence
  • Experience with exposure to various regulatory bodies, such as US FDA, MHRA, EMA, TGA, and Health Canada
  • Registered trainers at international organizations
  • Conducted 15+ presentations/webinars at global platforms, such as DIA, RQA, SQA, and PIPA
pharmacovigilance consulting services
Accreditations
  • Extensive experience in supporting successful 70+ Regulatory Inspections in last three years.
  • ISO accreditations received:
    ISO 9001:2015 (QMS)
    ISO 27001:2022 (ISMS)
    ISO 27701:2019 (PIMS)

How can we work together for better health?

Contact Us

Testimonials

  • 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
  • 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
  • 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
  • Medical Advisor, Medical Affairs
  • Global Clinical Leader
  • Associate Submission Medical Writer
  • Medical Director
  • QPPV and Pharmacovigilance Head
  • Senior Director
  • Head, Clinical Trial Transparency
  • AVP, Pharmacovigilance
  • Senior Director

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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.

    ©2024 APCER Life Sciences, Inc. All rights reserved. | Privacy Policy | Web User Agreement

    Services

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