About us
We are a pool of autonomous and proactive professional people specialized in pharmaceutical field, able to solve Companies problems thanks to a solution-oriented approach; unique interface for outsourcing pharmacovigilance activities. We work together with Clients to create quality, proposing easy and feasible solutions, tailored to each Company environment and in compliance with applicable laws.
When your energies finish, our energies start!
Some example of services provided to Clients (more than 60 Clients):
- Roles of QPPV or PVQA
- Training to QPPV, safety staff and Quaality staff on Pharmacovigilance and Quality in Pharmacovigilance (including ISO principles)
- audits to Pharmacovigilance and Quality systems and processes, and due diligence
- Creation/update of Standard Operating Procedures, Quality Manuals, Pharmacovigilance Agreements
- Creation of PV system for Marketing Authorization Holders, distributors, service providers
- Creation of PV training material
- Presentation to top management to explain pharmacovigilance requirements and challanges
- SWAT analysis of pharmacovigilance office processes
- Validation of excel file
- Management of Privacy in Pharmacovigilance
- And much more!
Professional development
Lucilla Strano Rossi, Managing Director.
I have been working in pharmacovigilance since 1995, starting in Pfizer – leading pharmacompany – and then as a Consultant, creating nEXOLUTION Pharma in 2008.
During these over 30 years of exclusive pharmacovigilance activity I have been local Qualified Person for Pharmacovigilance and QPPV, and I have personally managed procedures, audits, licensing agreements, training (QPPV, Safety staff, QA, sales reps, investigators), periodic reports, spontaenous and clinical trial reports, Pharmacovigilance System Master Files, product complaints, optimization of processes and resources, safety issues, and challanges during merges. I have been engaged with people, projects and time management, public relations, networking with Italian and foreign colleagues.
Passionated about communication and personal growth, I continuously keep myself updated on my professional technical skills and on other topics.