Pharmacovigilance plays a crucial role within the realms of Compliance and Quality Assurance, where instinct and intuition enhance established methodologies. The synergy between experience and efficiency fosters a transformative culture in Safety and Risk Management, paving the way for more effective practices.
At IntuVigilance, we pride ourselves on our diverse team of subject matter experts who are well-equipped to meet your Drug Safety and Pharmacovigilance requirements. Our commitment to providing innovative and thorough solutions is deeply rooted in the core values and principles that define IntuVigilance.
What distinguishes us in the competitive Pharmacovigilance landscape is our consultative approach and strategic alliances with both leading pharmaceutical companies and small to medium enterprises (SMEs). We prioritize the development of solid Pharmacovigilance frameworks and have cultivated a reputation as reliable, long-term partners within the industry, earning the trust of our clients through our dedication and expertise.
IntuVigilance Limited is an ISO certified organisation currently holding 5 certificates:
IntuVigilance has established itself as the premier organization for both local and international literature monitoring services. Our comprehensive weekly centralized screening service is meticulously conducted by our Qualified Person Responsible for Pharmacovigilance (QPPVs), who carry out thorough reviews and assessments.
This centralized approach not only enhances the efficiency of safety surveillance activities but also represents a highly cost-effective solution for our clients. By leveraging our expertise, we ensure that safety monitoring is optimized, allowing organizations to focus on their core operations while we manage the complexities of literature monitoring with precision and reliability.
Our team of expert project managers in pharmacovigilance (PV) systems provides comprehensive oversight and coordination for our clients, ensuring effective management both at the central and local levels.
These professionals are instrumental in the development and maintenance of a wide range of essential PV documentation, including Product Safety Management Files (PSMFs), Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Safety Summary Reports, and Safety Plans, among others.
With a robust global expertise in Qualified Person for Pharmacovigilance (QPPV), we are adept at preparing local Product Safety Summary Files (PSSFs) and PSURs in compliance with national regulations across various jurisdictions. Our extensive experience in these regions equips us with a thorough understanding of local requirements and specifications, ensuring that all documentation is not only accurate but also aligned with the specific legal frameworks governing each territory.
IntuVigilance offers comprehensive case management and rapid reporting services through our Argus SaaS safety database, which is R3 ready. We serve as a global safety database custodian for our clients, leveraging a diverse team located across Latin America, the United Kingdom, and India to efficiently manage a wide array of case management tasks.
Our skilled case processors are adept at overseeing all aspects of case management, ensuring that every detail is meticulously handled. The Argus platform features integrated gateway connections that facilitate smooth and expedited reporting to regulatory authorities and agencies, enhancing our clients’ compliance and operational efficiency.
IntuVigilance offers a comprehensive array of standard operating procedures, policies, working instructions, and guidelines that form the backbone of our Quality Management System (QMS). This system encompasses critical processes across pharmacovigilance (PV), quality assurance (QA), human resources (HR), and information technology (IT), ensuring a cohesive operational framework.
We are adept at assisting our clients with gap analyses and the development and upkeep of their processes, thereby enhancing their operational efficiency. Our established procedures are consistently integrated into client contracts, reflecting our commitment to quality and compliance.
Furthermore, our QMS undergoes regular evaluations and receives approval from industry auditors, underscoring our dedication to maintaining high standards and continuous improvement in our services.
Partner and vendor audits play a crucial role in the effectiveness of a pharmacovigilance (PV) system. Our team comprises trained professionals who are adept at planning and executing these audits to ensure compliance and operational excellence.
IntuVigilance actively engages in audit processes and has established comprehensive procedures to assist clients in preparing for inspections. To maintain a high level of awareness regarding changes within the PV system, we conduct regular audits of the IntuVigilance PV universe. Our project managers hold quarterly oversight meetings with our global partners, ensuring that the management of the PV system remains effective and aligned with best practices.
Although audits and inspections in the PV domain have been in place since the establishment of the MHRA PV Inspectorate in 2004, the emphasis on the quality of the PV system has intensified following the introduction of new Good Vigilance Practice (GVP) modules in 2012. This shift has integrated a risk-based approach into the legislative framework, underscoring the importance of maintaining rigorous standards in pharmacovigilance.
IntuVigilance has established a comprehensive training program that is intricately aligned with its Quality Management System (QMS) framework. This program not only enhances internal capabilities but also extends to our clients, offering pharmacovigilance (PV) awareness training tailored for sales teams and non-PV staff in affiliate offices.
Through our PV Academy, we deliver both pre-designed and customizable training modules, ensuring that our highly experienced faculty is readily available to provide mentorship and address the specific training requirements of individuals. This approach guarantees that all participants receive the support they need to excel in their roles and maintain compliance with industry standards.
The foundation of our operations in drug safety and pharmacovigilance is built upon the global requirements set forth by various countries. It is essential to be well-versed in the relevant legislation of each jurisdiction, utilize the most up-to-date information, and stay informed about the evolving regulatory landscape, which presents a significant challenge for the industry as a whole.
Drawing from decades of expertise in this field, IntuVigilance has created a comprehensive regulatory collection system known as ikyzen. This innovative platform offers precise, country-specific reporting guidelines that are easily accessible to our clients, ensuring they remain compliant with local regulations.
For further details about ikyzen, we invite you to explore its dedicated website through the provided link.
“IntuVigilance provided EU QPPV as well as local QPPV, literature monitoring and expedited reporting services; plus support with Risk Management Plans services to the company. Their experience, knowledge and efficiency was vital to our ability to meet all requirements.
They demonstrated great professionalism and are successful in ensuring all the pharmacovigilance requirements were met. Importantly, they blended seamlessly into the existing PV team and the company as a whole and very quickly became a vital part of the company.”
“Nimisha Kotecha stepped in as interim QPPV for a UK based pharmaceutical client and went through MHRA inspection with a favourable outcome. IntuVigilance provides a high quality, yet cost efficient, service to our big and small pharmaceutical clients.
We highly recommend IntuVigilance to any pharmaceutical company with regulatory presence in the EU that needs an excellent all-round service provider focusing on pharmacovigilance, risk and quality management.”
“Over the past 5 years working with the IntuVigilance team I have found them to be professional, supportive and flexible. They took the time to understand our company’s requirements and provide us with an external drug safety department that handles our global safety database as well as providing study support on an ongoing basis.
It is reassuring to be working with such a capable team headed up by Nimisha, who, as a seasoned PV professional provides excellent leadership and stewardship.”
“I have been collaborating with IntuVigilance and specially with Nimisha among several pharmacovigilance projects. Nimisha is managing the IntuVigilance team, which is always responding with professionalism to the most complicated projects.
Nimisha is hardworking, committed and trustworthy professional, with an excellent knowledge in strategic and operational pharmacovigilance. She is also an expert in pharmacovigilance legislation. Besides, she is an innovative thinker, and she is anticipating changes in the field.”
“The professional support provided by IntuVigilance through Nimisha Kotecha during a period of 8 months was essential to replace ad interim the roles of Director of PV and the QPPV for all our clients.
During that period she was able to leverage the PV Department to an autonomous business unit, to bring confidence to our clients, to create the platform for future growth and to maintain stable PV activities until the new permanent Director of PV took over the lead.”
“Our Company has worked with IntuVigilance for 5 years and they have held our global safety database since 2017 and functioned as our Company’s external drug safety department since then. We find Nimisha and her team to be very professional and knowledgeable in the drug safety arena and we rely heavily on them to fill an expertise gap in our small, virtual Company.
I would have no hesitation in recommending IntuVigilance for the provision of drug safety services and look forwarding to continuing our relationship with them as we progress through our clinical development programme.”
IntuVigilance Ltd will identify areas of strengths and weakness environmentally within the overall business and attempt to substantially reduce the potential impacts to air, surface water, ground water, public health, community quality of life and employee health, while producing high quality service to its clients.
We consider the health and safety of each of our employees to be of primary importance. Our objective is to conduct our business in the safest possible manner consistent with the Occupational Health & Safety Act. We recognise the right of workers to work in a safe and healthy work environment.
Our policy is to exercise due diligence to protect Information Systems from unauthorised access, use, disclosure, destruction, modification, disruption or distribution. It is our responsibility to ensure all contractual, business, legal and regulatory requirements are considered alongside our information security obligations.
We are committed to successful collaboration to ensure our customers and clients are educated in IntuVigilances’ quality expectations, ensure GxP regulations are met, best practices are incorporated and that robust and effective quality processes are developed, followed and constantly improved.
The ISO 22301 business continuity management standard, crucially helps organisations identify and prioritise threats. It allows them to implement their business continuity management system effectively so they are ready to respond to and recover from incidents with the least disruption to business.