At Pharmaceutical Innovation Services S.L., we understand that Pharmacovigilance (PV) is a cornerstone of patient safety and regulatory compliance in the pharmaceutical industry. Our commitment to excellence is reflected in the comprehensive suite of pharmacovigilance services we offer, designed to meet the stringent requirements of regulatory authorities while maximizing the market potential of your products.

With a global team of Pharmacovigilance experts, including experienced PhV physicians and a dedicated medical writing group, we provide tailored solutions and the highest quality services, fully aligned with industry standards and regulatory demands.

The Importance of Pharmacovigilance

Pharmacovigilance is not just a regulatory requirement; it is an ethical obligation that ensures the safety and well-being of patients who rely on pharmaceutical products. As the pharmaceutical landscape evolves, with new drugs and therapies entering the market at an unprecedented pace, the need for robust pharmacovigilance systems has never been greater. Pharmaceutical Innovation Services S.L. is here to help you navigate these complexities, offering services that go beyond mere compliance to actively manage and optimize the risk-benefit profile of your products.

Tailored Pharmacovigilance Solutions

Every pharmaceutical company has unique needs and challenges, which is why we offer tailor-made Pharmacovigilance solutions to meet specific requirements. Whether you need to outsource individual Pharmacovigilance activities or require a fully managed global Pharmacovigilance System, we have the expertise and resources to deliver what you need.

Risk Management Plan (RMP) Elaboration

A well-constructed Risk Management Plan (RMP) is essential for identifying, assessing, and mitigating potential risks associated with a medicinal product. Our experts at Pharmaceutical Innovation Services S.L. will work closely with your team to develop comprehensive RMPs that not only meet regulatory requirements but also contribute to the safe and effective use of your products. Our approach to RMP elaboration is thorough and data-driven, ensuring that all potential risks are identified and appropriate measures are put in place to manage them.

Global and Local Literature Searches

The medical literature is an important source of information for the identification of suspected adverse reactions to authorised medicines. We conduct global and local literature searches to identify relevant safety information, adverse events, and emerging signals that may impact the risk-benefit profile of your products. The frequency of these searches is tailored to your needs and regulatory obligations, making sure no critical information is overlooked. Our team also manages case reconciliation and signal detection, delivering actionable insights to guide your Pharmacovigilance strategy.

Management of ICSR and L2A Cases (EudraVigilance)

Individual Case Safety Reports (ICSRs) and Line Listings (L2A) are critical components of pharmacovigilance, particularly in the context of EudraVigilance. Pharmaceutical Innovation Services, S.L., specializes in the management of ICSR and L2A cases, with a focus on accurate preparation, submission, and monitoring in accordance with EU regulations. Our detailed approach to case management helps identify and address potential safety concerns promptly.

Maintenance of Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)

The Extended EudraVigilance Medicinal Product Dictionary (xEVMPD) is a key element of the EU’s Pharmacovigilance system, requiring accurate and up-to-date information on all medicinal products authorized in the European Economic Area. Our team is proficient in the maintenance of xEVMPD, making sure your product data is correctly entered and maintained within the system. This service is critical for meeting regulatory requirements and facilitating the smooth operation of your Pharmacovigilance activities.

Pharmacovigilance Training and Audits

Ensuring that your team and partners are well-versed in Pharmacovigilance best practices is essential for maintaining compliance and safeguarding patient safety. We offer comprehensive Pharmacovigilance training programs adapted to the specific needs of your organization. These training sessions cover all aspects of Pharmacovigilance, from basic principles to advanced regulatory requirements. This way, your staff will be fully trained to manage Pharmacovigilance activities effectively.

In addition to training, Pharmaceutical Innovation Services, S.L., provides rigorous audits of your Pharmacovigilance Systems, whether internal or involving third parties such as vendors or partners. Our audits are designed to identify potential gaps in your Pharmacovigilance processes and provide recommendations for improvement. We also support your company during inspections by regulatory authorities, helping you to prepare thoroughly and address any issues that may arise.

Regulatory Support and Safety Communications

Navigating the regulatory landscape is a complex and challenging task, especially when it comes to Pharmacovigilance. We offer expert support in managing interactions with regulatory authorities, including the management of urgent safety communications. Whether you need to communicate new safety information, respond to a regulatory inquiry, or manage deviations and CAPAs (Corrective and Preventive Actions), our team is here to help you deliver clear communications that are accurate and compliant with regulatory requirements.

Effective Pharmacovigilance requires ongoing monitoring and continuous improvement. We provide comprehensive monitoring services to track the performance of your Pharmacovigilance System, identify areas for improvement, and implement necessary changes. Our goal is to help you maintain a high level of Pharmacovigilance performance, and confirm that products remain safe and effective throughout their lifecycle.

Pharmacovigilance is a critical function that requires expertise, diligence, and a deep understanding of both regulatory requirements and patient safety concerns. Our global team of Pharmacovigilance experts is committed to delivering high-quality services that meet your specific needs, from risk management and literature searches to case management and regulatory support.

How do the Pharmacovigilance Services of Pharmaceutical Innovation Services, S.L.,ensure the safety and compliance of your products?

With our tailored Pharmacovigilance solutions, you can be confident that your products are in safe hands, allowing you to focus on your core business activities while we take care of the complexities of pharmacovigilance. Partner with us to ensure that your Pharmacovigilance System is compliant with regulatory requirements, is robust and capable of supporting the successful marketing of your pharmaceutical products.