Dipl.Biol., MBA, PMP, MRQA
Co-Founder
BA Combined Hons, Advanced Dipl. HonPIPA, MRQA
Co-Founder
Whether building your first pharmacovigilance system, preparing for commercial launch, or optimizing an existing one, the goal remains a compliant, efficient, and scalable PV ecosystem. For growing companies, achieving and maintaining this with limited resources is a significant challenge. A clear strategic approach is critical for success.
The Challenge: A collection of disconnected processes creates compliance risks and cannot scale effectively.
The Solution: A cohesive, right-sized PV ecosystem. This integrated framework of processes, technology, and quality management ensures compliance and is built to grow with your company.
The Challenge: The shift from clinical to commercial brings intense new regulatory demands that can overwhelm a launch
The Solution: A clear guidance to build commercial-stage PV capabilities. This ensures a smooth, compliant transition and a successful market entry.
The Challenge: A vendor mismatch leads to compliance gaps, data issues, and escalating costs.
The Solution: A structured selection and governance process. This results in a partnership with a vendor that fits your specific needs and acts as a seamless extension of your tea
The Challenge: Establishing and maintaining a compliant validation framework for all computerized systems is a continuous and resource-intensive demand, often distracting teams from core duties
The Solution: Expert-led development of a validation framework and project execution. This ensures all systems are validated efficiently and maintained in a compliant state, ensuring data integrity and inspection-readiness.
For a growing company, an upcoming regulatory inspection can feel like a threat. But it doesn’t have to be. A strategic, risk-based approach to auditing transforms compliance from a reactive burden into a proactive asset. It provides the certainty that your systems are not just compliant today, but resilient for tomorrow’s growth and scrutiny.
The Challenge: Your procedures look compliant on paper, but are they effective in practice? Hidden gaps in your PV system—across human and animal health—can become major findings during a regulatory inspection.
The Solution: A comprehensive, independent audit. This provides an objective assessment of your true compliance posture, identifying systemic risks before they escalate and delivering a clear roadmap for remediation.
The Challenge: Managing a complete audit program (internal, vendor, and partner audits) is a significant drain on lean teams, often leading to inconsistent oversight and last-minute scrambles.
The Solution: A fully-managed, risk-based audit program. This provides continuous oversight and assurance in a sustainable, cost-effective way, turning auditing into a predictable strategic tool and freeing your team to focus on core priorities.
The Challenge: The pressure of an impending inspection creates uncertainty. Are there critical gaps you’ve missed? Is your team truly prepared to face regulators?
The Solution: A simulated “mock” inspection and detailed gap analysis. This identifies vulnerabilities before inspectors do and provides targeted readiness training, equipping your team and systems with the confidence and preparation needed for a successful outcome.
While the principles of safety monitoring are universal, their application in specialized markets like animal health and cosmetics demands specific expertise.
These sectors have unique regulatory frameworks, risk profiles, and business drivers that require a tailored vigilance approach, not just a modification of standard GVP.
The Challenge: The regulatory landscape for animal health (Regulation (EU) 2019/6) is built on GVP foundations but has critical distinctions. A compliant veterinary pharmacovigilance system must account for species-specific reactions, the safety of non-target animals, human exposure to veterinary products, and the environmental impact of their use. Furthermore, for food-producing animals, managing Maximum Residue Limits (MRLs) adds another layer of complexity. Simply adapting a human PV system is insufficient and will fail to meet the specific requirements for the Pharmacovigilance System Master File for Veterinary use (PSMF-v) or the reporting standards for EudraVigilance Veterinary (EVVet).
The Solution: A dedicated veterinary PV system designed for the nuances of VGVP. This approach ensures your PSMF-v is complete and inspection-ready, that all adverse event data is correctly processed and reported to EVVet, and that benefit-risk assessments are conducted in the context of animal health, herd management, and food safety. This provides the robust framework needed to operate successfully and maintain compliance in the veterinary market.
The Challenge: The EU Cosmetic Products Regulation (EC No 1223/2009) places significant responsibility on the designated “Responsible Person.” Unlike pharmaceuticals, cosmetics have a high volume of direct consumer use, leading to a wide spectrum of feedback, from minor complaints to potential Serious Undesirable Effects (SUEs). The challenge
lies in efficiently capturing and assessing this data to identify true safety signals while maintaining the Product Information File (PIF) and its Cosmetic Product Safety Report (CPSR). A failure in this process not only risks regulatory action but can quickly erode consumer trust and cause lasting brand damage.
The Solution: A streamlined cosmetovigilance system that protects both consumers and your brand. This framework provides a clear process for the intake, evaluation, and reporting of SUEs, ensuring full compliance with regulatory timelines. It supports the Responsible Person by bringing structure to safety data management, safeguarding the integrity of the PIF, and ultimately protecting the brand reputation you have worked hard to build.
The Challenge: For a growing company, every external inquiry—from a physician, patient, or pharmacist—is a dual responsibility. It’s a chance to provide value and build trust, but it’s also a critical compliance checkpoint. Without a dedicated Medical Information team, inquiries can become a significant source of risk. Scattered requests across emails and voicemails, inconsistent answers, and—most critically—the failure to identify and report potential adverse events can lead to serious compliance gaps and undermine patient safety.
The Solution: A robust Medical Information process that turns this risk into an asset. This involves creating a centralized system to manage all inquiries, ensuring that every interaction is documented. Potential adverse events and product quality complaints are systematically identified, triaged, and reported to the correct pharmacovigilance or quality channels within regulatory timelines. By developing standardized, evidence-based responses (FAQs and Standard Response Documents), your organization provides consistent and accurate information to all stakeholders. This structured approach not only ensures compliance but also transforms your Medical Information function into a valuable source of real-world data for trend analysis and risk management.
An independent audit is a critical element of a strong quality system. It provides an objective, unbiased assessment that creates a clear baseline for improvement. The goal of every audit is to provide clarity, empowering you to strengthen your compliance and operational effectiveness.
With the clear results from an audit as your guide, the journey to implement improvements can begin. A continuous partnership, where the deep context from the audit informs the advisory phase, offers a highly efficient path. This approach ensures the insights from the audit are translated directly into effective, sustainable solutions, accelerating your progress toward greater compliance and inspection-readiness.
Our audit function operates with complete independence to deliver a clear and objective assessment of your system. The final report is a comprehensive, standalone record of findings.
With the objective findings in hand, you are in full control. You can choose to manage remediation internally or with any partner.
Should you decide to continue the partnership, a new advisory engagement begins. This phase leverages the deep understanding gained during the audit to design and implement effective solutions with maximum efficiency. This direct translation of insight into action ensures a faster, more effective resolution.
This sequenced approach honors the independence required of an audit while offering the momentum of a unified partnership. It provides a clear, efficient, and conflict-free path from insight to implementation.
Viginext Advisors GmbH
Mafinex Technology Center
Julius-Hatry-Str. 1
68163 Mannheim
Germany
Viginext Ltd.
3a Rosemary House,
Lanwades Business Park,
Kennett, Newmarket, CB8 7PN
United Kingdom