Your Drug Safety
and
PV partner of choice
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.
Vision: Safety without compromise.
Values: Intuitive, compassionate, and ethical pharmacovigilance.
Where the essence of Pharmacovigilance is catered for within the discipline of Compliance and Quality Assurance. Where intuition and instinct walk alongside tested methodology. Where experience and efficiency join hands to create a new culture in Safety and Risk Management.
IntuVigilance boasts a plethora of subject matter experts to suit your Drug Safety and PV needs. Our team is dedicated to providing innovative and diligent solutions that are synonymous with the ethos and values of IntuVigilance.
Our USP within the competitive world of PV services lies in our consultative prowess and strategic partnerships with top tier pharma as well as SME organisations. We help to build strong PV foundations and are long-standing trusted partners within the Industry.
IntuVigilance Limited is an ISO certified organisation currently holding 5 certificates:
Services
IntuVigilance builds in strong relationships with its customers. We are a considerate and reliable partner who readily interprets its clients’ needs and delivers with high quality, compliance, and skill. We pledge to provide a cost-competitive, time efficient and transparent service to our customers.
Please feel free to browse through our service offering here:
Please feel free to browse through our service offering here:
QPPV supply and coordination
IntuVigilance is the industry leader in the supply of EU as well as local QPPVs and Safety officers around the world.
Our global footprint includes North America/Canada, LATAM, EU/EEA, Middle East, Africa, Asia Pacific, Russia and CIS countries.
GVP Module 1 , UK Statutory Instrument 2012, along with myriad global regulations mandate a QPPV requirement in their territories. IntuVigilance maintains a pool of qualified and available QPPVs to support your needs with minimal on-boarding effort.
Scientific Literature Monitoring
IntuVigilance has long since been the go-to organisation for local as well as global literature monitoring services. We offer a weekly centralised screening service with review and assessments completed by our QPPVs. This centralised offering is a highly cost effective and efficient solution whilst ensuring optimised safety surveillance activity.
Pharmacovigilance System Oversight
Our team of highly skilled PV project managers ensure oversight and coordination of our clients’ PV system both centrally as well as locally.
Our project managers support the production and maintenance of a variety of PV documents: PSMFs, RMPs, PSURs, DSURS, Safety Summary reports, Safety Plans, etc.
Our global QPPV expertise includes preparing local PSSFs and PSURs where mandated by national legislation in worldwide territories. Our experience in such territories means that we have visibility of local requirements and specifications when producing such documents.
Pharmacovigilance and Drug Safety Operations
IntuVigilance provides full-service case management and expedited reporting services using our Argus SaaS safety database (R3 ready). We act as a global safety database holder for our customers. We also serve as the EU safety department for our customers in USA.
Our team of case processors manage the breadth and width of case management activities. In-built gateway connections within Argus allow for seamless expedited reporting to Regulatory Authorities as well as Agencies.
Standard Operating Procedures
IntuVigilance hosts a robust suite of standard operating procedures, policies, working instructions and guidelines. Our QMS includes PV, QA, HR and IT system processes.
IntuVigilance is well equipped to support its customers with gap analysis and preparation and maintenance of client processes.
Our own procedures are utilised routinely within client contracts. Our QMS is regularly scrutinised and approved by auditors within the industry.
Audits and Inspections
Partner and vendor audits are integral to a successful PV system. We provide trained experts to plan and conduct audits.
IntuVigilance regularly participates in audits and has developed robust procedures to support its clients with Inspection readiness activities.
The IntuVigilance PV universe is routinely audited to ensure a thorough awareness of PV system changes. Our project managers routinely conduct quarterly oversight meetings with our global partners to ensure PV system management.
Audits and Inspections in the PV universe is not a new concept with the MHRA PV Inspectorate being established in 2004, although, the focus on the PV quality System has increased in the introduction of the new GVP modules in 2012 making the risk-based approach now part of legislation.
Training
IntuVigilance has a robust training schedule developed around its own QMS infrastructure. In addition, we support our clients with PV awareness training for sales force, as well as non-PV personnel within affiliate offices.
We provide ready-made or customisable training programmes through our PV Academy wherein our highly skilled faculty is always at hand to support mentorship and individual training needs.
Regulatory Intelligence Database
Global country requirements form the basis of everything we do within drug safety and pharmacovigilance. Knowing the legislation in concerned countries, ensuring that you use the most current information and keeping on top of changing legislative requirements is a challenge across the Industry.
Based on decades of experience in this area, IntuVigilance has developed a regulatory collection system called ikyzen, that provides on-point country specific reporting rules that are readily available to our customers. For more information on ikyzen, please visit its website via this link
Consulting
Advisory as well as consultative service to help customers develop operational excellence within their own departments.
Solutions
Implementation and customisation of safety operations solutions.
Success
On-point operational execution of projects utilising the wealth of experience and industry know-how.
Always delivering
positive change
Our team is dedicated to providing innovative and diligent solutions that are synonymous with the ethos and values of IntuVigilance
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.
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.
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.
Admin SupportNoah
Gibson
Noah has been part of the team for nearly 2 years as an administrator, for both the PV and QA sides of the business. Among the duties and tasks include involvement with projects, SUSARs, DSURs, and helping to maintain the LMS that allocates training to all necessary personnel.
Companies who recognise our world class services:
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.
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.”
IntuVigilance ISO Polices
IntuVigilance Limited is an ISO certified organisation currently holding 5 certificates: ISO9001, ISO14001, ISO45001, ISO27001 and ISO22301
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.
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.
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.
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.
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.
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We have a proven track record of service deliverables within the industry. We are your preferred partner. Let’s connect!
News & Articles
ISO Polices
IntuVigilance Limited is an ISO certified organisation currently holding 5 certificates:
• ISO9001
• ISO14001
• ISO45001
• ISO27001
• ISO22301
• ISO9001
• ISO14001
• ISO45001
• ISO27001
• ISO22301
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