Nimisha Kotecha and her highly capable team at Intuvigilance has provided a very reliable and professional service as QPPV and Deputy QPPV for our clients. As part of this activity they have taken on a variety of projects from thorough review of medical literature and working to tight deadlines through to delivering excellent analytical services in signal management, pharmacovigilance and risk management of medicines.

The Intuvigilance team have also taken on key roles in EudraVigilance including trusted deputy, managing user registration and XEVMPD. Nimisha has a robust quality system in place at Intuvigilance which has been assessed favourably by both internal and external auditors.

Managing Director (Service Provider)

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.

Head of Safety and EU QPPV, Alimera Sciences Ltd

Intuvigilance stepped in as interim QPPV for a UK based pharmaceutical client of ours 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 focussing on pharmacovigilance, risk and quality management.

Medical Director & EU QPPV (Service Provider)

Intuvigilance worked with us at a very important stage in the company’s development. They provided EU QPPV as well as local QPPV, literature monitoring and expedited reporting services; plus support with Risk Management Plans.

The experience, knowledge and efficiency that they brought with them was vital to our ability to meet all requirements. Importantly, they blended seamlessly into the existing PV team and very quickly became a vital part of the company’.

Senior VP and MD Europe, (Pharma)

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.

Dr. Carlos Camozzi, Group Chief Medical Officer, Simbec-Orion Group Limited

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.

Mr. Jose Alberto Ayala Ortiz, PVpharm CEO, EU QPPV, EudraVigilance EVWeb-XEVMPD Trainer