https://intuvigilance.com/wp-content/uploads/2023/05/Intu_colour1.png

Your Drug Safety
and
PV partner of choice

https://intuvigilance.com/wp-content/uploads/2023/05/Intu_colour1.png

Your Drug Safety
and
PV partner of choice

We are IntuVigilance

Mission: Proactivity over reactivity.
Vision: Safety without compromise.
Values: Intuitive, compassionate, and ethical pharmacovigilance.

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:

About_Us
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-1.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-2.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-10.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-9.png
https://intuvigilance.com/wp-content/uploads/2023/05/Services.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-7.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-2.png

Services

IntuVigilance is dedicated to fostering robust relationships with its clients, positioning itself as a thoughtful and dependable partner. Our team excels in understanding and interpreting the unique needs of each customer, ensuring that we deliver services characterized by exceptional quality, strict compliance, and expert execution. We are committed to offering a service that is not only cost-effective and time-efficient but also transparent, allowing our clients to have a clear understanding of our processes and outcomes. This commitment to excellence and customer satisfaction is at the core of our operations, as we strive to exceed expectations and build lasting partnerships.

Please feel free to browse through our service offering here:
Global QPPV Services
  • IntuVigilance is a leading provider of EU and local Qualified Person Responsible for Pharmacovigilance (QPPV) services and Safety Officers worldwide.
  • Our global presence spans North America, Canada, Latin America, the EU/EEA, the Middle East, Africa, Asia Pacific, Russia, and the CIS countries.
  • We expertly manage all pharmacovigilance-related inquiries from health authorities, ensuring compliance and safety in drug monitoring.
  • We specialize in creating comprehensive pharmacovigilance systems tailored to meet the specific needs of each client.
  • IntuVigilance has a readily accessible pool of qualified QPPVs, facilitating seamless integration with minimal onboarding requirements.
  • Our robust monitoring processes involve the systematic collection, analysis, and sharing of regulatory updates at global, regional, and local levels.
  • Our range of services generally includes the appointment of a QPPV to oversee the pharmacovigilance system, the maintenance of the Pharmacovigilance System Master File (PSMF), management of safety data, and coordination with local pharmacovigilance representatives (LPPVs) to ensure compliance with country-specific regulations.
Scientific Literature Monitoring

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.

Pharmacovigilance System Oversight

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.

Pharmacovigilance and Drug Safety Operations

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.

Standard Operating Procedures

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.

Audits and Inspections

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.

Training

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.

Regulatory Intelligence Database

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.

Consulting

We provide advisory and consultative services designed to assist clients in achieving operational excellence within their departments.

Solutions

The deployment and tailoring of safety operations solutions are essential for enhancing organizational security and efficiency.

Success

Effective execution of projects is achieved by leveraging extensive experience and industry expertise.
https://intuvigilance.com/wp-content/uploads/2023/05/new_bgn.png

Always delivering
positive change

Our team is dedicated to providing innovative and diligent solutions that are synonymous with the ethos and values of IntuVigilance
https://intuvigilance.com/wp-content/uploads/2023/05/new_bgn.png

Always delivering
positive change

Our team is dedicated to providing innovative and diligent solutions that are synonymous with the ethos and values of IntuVigilance

IntuVigilance team

Our team has a collective expertise that spans four decades in Drug Safety and PV activities. Our professional experts understand the principles of drug safety and PV and offer in-depth knowledge and insight into current trends and practice.
Nimisha Kotecha

Managing DirectorNimisha
Kotecha

Nimisha is the founder and Managing Director of the Company, with over 25 years of experience within the industry. She has served as a QPPV for numerous companies and has an innate passion for all things drug safety and pharmacovigilance. She believes in empowering her team and embodies customer relations and leadership values in a unique and versatile manner.
Reni Kunkel

Global PV Ops ManagerReni
Kunkel

Reni is the Global PV Operations Manager, with over 14 years of experience within PV in different pharmaceutical companies such as GW Pharmaceuticals, Jazz Pharmaceuticals and Mundipharma.
Harpreet Koasha

Senior Project ManagerHarpreet
Koasha

Harpreet has over 10 years of experience with a proven track record in supporting clients with an array of study needs, from study start-up through to close out.
Henna Gupta

Project ManagerHenna
Gupta

Henna is an expert in the management of clinical trial safety management and post-marketing PV, with a good understanding of global safety and any other relevant regulations.
https://intuvigilance.com/wp-content/uploads/2024/09/Ximena-Manglano-Liendo-640x640.jpg

Senior PV Manager LATAMXimena
Manglano Liendo

Ximena is a medical doctor, with over 18 years of working in the pharmaceutical industry, and vast experience in drug safety, compliance and medical information.
Janice Fuller

Quality SpecialistJanice
Fuller

Janice worked in a range of operational and managerial roles for companies such as Amgen, Baxter, Bristol Myers Squibb, Mundipharma and others, building a strong understanding of international teams and the regulated PV environment.
https://intuvigilance.com/wp-content/uploads/2023/10/Nishil-Lakhani.jpg

Senior QA SpecialistNishil
Lakhani

Nishil has worked in the pharmaceutical industry for over 3 years in varied QA roles including finished product release, management of a successful QMS, audits, inspections and now adding pharmacovigilance and drug safety to his experience.
Adarsh Parmar

Senior PV ScientistAdarsh
Parmar

Adarsh has more than nine years of experience in PV including triage, coding, validation and quality review of ICSRs. Performing case processing of ICSRs to ensure high quality of safety reports in accordance with client SOPs and regulatory requirements.
Anya Kotecha

RIO Lead & ikyzen SMEAnya
Kotecha

Anya has been a part of the team for over 4 years, focused on developing and enhancing the Regulatory Intelligence Office (RIO). She currently serves as the RIO Lead and ikyzen SME within the business, and manages the ikyzen infrastructure and processes whilst working closely with the software development team.
Sarena Lakhani

PV ScientistSarena
Lakhani

Sarena is our newest recruit who joined us in 2023 following her graduation in Biomedical Sciences. She works as a PV Specialist within the drug safety and pharmacovigilance department supporting case management, QPPV operations and the ikyzen team.
https://intuvigilance.com/wp-content/uploads/2023/05/new_bgn.png
https://intuvigilance.com/wp-content/uploads/2023/05/new_bgn.png
https://intuvigilance.com/wp-content/uploads/2023/05/new_bgn.png

Join our team

Companies who recognise our world class services:

https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-5.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-2.png
Abbvie
Abivax logo
antev
avilion
bangor
biocept
celldex
CL_Behring
glenmark
isglobal
italfarma
itm
janssen
jazz
kk
labcorp
merck
novavax
omeros
paratek
pfizer
pg
propharma
reckitt
takeda
unilab

Changing your perception

We are a compassionate group that interweaves knowledge with human factors to understand our clients and their needs. This allows us to bring our own unique brand of service to our customers.
IntuVigilance blended seamlessly into the existing PV team and the company as a whole and very quickly became a vital part of the company.
Head of Safety and EU QPPV
I would have no hesitation in recommending IntuVigilance for the provision of drug safety services and look forwarding to continuing our relationship with them.
VP, Global Clinical Operations
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-4.png
Over the past 5 years working with the IntuVigilance team I have found them to be professional, supportive and flexible.
VP Clinical Operations
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-10.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-9.png

Testimonials

Our testimonials are a reflection of our unique blend as we bolster our stronghold on Drug Safety and PV services within the Industry.
Head of Safety and EU QPPV, Pharmaceutical company

“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.”

Medical Director & EU QPPV Service Provider

“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.”

VP Clinical Operations- Pharmaceutical company

“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.”

CEO PV Service Provider, EU QPPV, EudraVigilance EVWeb-XEVMPD Trainer

“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.”

Group Chief Medical Officer, CRO

“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.”

VP, Global Clinical Operations, Pharma

“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.”

Testimonials
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-1.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-2.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-10.png
https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-9.png

IntuVigilance ISO Polices

IntuVigilance Limited is an ISO certified organisation currently holding 5 certificates: ISO9001, ISO14001, ISO45001, ISO27001 and ISO22301
https://intuvigilance.com/wp-content/uploads/2023/05/hd-wallpaper-1001679_640.jpg

Environmental Management Systems ISO 14001

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.

https://intuvigilance.com/wp-content/uploads/2021/06/img-floater-4.png
https://intuvigilance.com/wp-content/uploads/2023/05/desktop-3207338_640.jpg

Health and Safety Management Systems ISO 45001

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.

https://intuvigilance.com/wp-content/uploads/2023/05/internet-3592056_640.jpg

Information Security Management Systems ISO 27001

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.

https://intuvigilance.com/wp-content/uploads/2023/05/concept-18290_640.jpg

Quality Management Systems
ISO 9001

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.

https://intuvigilance.com/wp-content/uploads/2023/05/network-3664108_640.jpg

Business Continuity Management
ISO 22301

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.

Get in touch with us

We have a proven track record of service deliverables within the industry. We are your preferred partner. Let’s connect!