Qinecsa pharmacovigilance consulting guide

Pharmacovigilance consulting is essential throughout the entire lifecycle of both commercial and clinical products.

At Qinecsa, a company with a strong focus and heritage on pharmacovigilance consulting, with years of successful safety services delivery enhanced by our innovative technologies, we are a proven, trusted partner to the life science industry.

We have successfully helped clients in many areas like people support, process establishment, system selection, and business transformation decisions, leveraging our deep domain expertise in services and technology.

What we can offer

Comprehensive pharmacovigilance services
Qinecsa’s suite of pharmacovigilance services includes, and is not limited to:

  • Pharmacovigilance consulting
  • Benefit-risk analysis
  • EEA and local qualified persons for pharmacovigilance (QPPV)
  • Safety Data Exchange Agreement (SDEA)
  • Risk management plans (RMPs) development
  • Pharmacovigilance system master file (PSMF)
  • Auditing services
  • Development of standard operating procedures (SOPs)
  • Post-marketing and clinical trial case processing
  • Validated safety databases
  • Aggregate report writing
  • Literature search
  • Regulatory reporting

Expertise across diverse therapeutic areas
Qinecsa supports clients with products authorized or under development in these diverse areas. Our extensive experience and proficiency span various therapeutic areas, including cancer treatments, infectious diseases, oncology, and cardiovascular diseases.

Consultation on clinical trials and development products
Qinecsa provides expert consultation on clinical trials and product development. Our medical doctors support trials through serious adverse event (SAE) medical reviews, signaling, and the review of development safety update reports (DSURs).

Assured quality through expert leadership
The expertise of Qinecsa’s pharmacovigilance consulting services is primarily ensured by our industry-renowned experts, alongside our pharmacovigilance technology professionals within our leadership team.

Empowering pharmacovigilance strategies
Our team empowers pharmacovigilance strategies, navigating complexities in processes, technology, and vendor optimization. Gain invaluable insights from our experts to elevate your approach and ensure compliance with confidence.

Building tailored solutions for enhanced patient care
Qinecsa approaches pharmacovigilance consulting as more than just routine. We prioritize offering tailor-made, comprehensive, top-quality, cost-effective, and innovative safety solutions that prioritize the quality of life for patients.

A robust network of key Roles of EEA, UK, and Local QPPVs
EEA, UK, and local qualified persons for pharmacovigilance (QPPVs) are pivotal in pharmacovigilance consulting. Qinecsa ensures comprehensive training and ongoing updates on key EU PV legislation for its QPPVs. Our robust network of skilled national persons responsible for pharmacovigilance (NPRPs) monitors local regulatory requirements in numerous countries.

EEA, UK, and local QPPVs play a significant role in pharmacovigilance consulting. A QPPV is required for medicinal products marketed within the EEA, overseeing various responsibilities such as establishing and maintaining the marketing authorization holder’s (MAH) PV system, serving as a single point of contact for regulatory authorities, and managing safety concerns. Qinecsa ensures that our QPPVs undergo comprehensive training, share experiences through an internal QPPV forum, and stay updated on crucial EU PV legislation and guidelines changes.

Extended services and expert support
Qinecsa’s pharmacovigilance consulting services extend to audits, inspections, and the preparation of SOPs. The company’s consultants and executives conduct global pharmacovigilance audits and work with client companies to ensure the comprehensive coverage of their pharmacovigilance systems. Creating and reviewing SOPs are ongoing processes tailored to each company and product, ensuring compliance and specificity.

Experienced Project Managers (PMs) at Qinecsa with excellent communication and management skills serve as key contact points for clients, fostering good relationships through regular communication and transparent monthly project status reports.

Connect with Qinecsa
Empower your pharmacovigilance strategy today by partnering with our experts to ensure optimized, compliant, effective pharmacovigilance solutions that cater to your specific needs while gaining invaluable insights and support.