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 40 Clients):

  • Roles of QPPV or PVQA
  • Audits to Pharmacovigilance and Quality Assurance offices, and due diligence
  • Creation/update of Standard Operating Procedures, Quality Manuals, Pharmacovigilance Agreements
  • Training on Pharmacovigilance and Quality in Pharmacovigilance (including ISO principles)
  • Re-organization of electronic and paper archive
  • Start-up of Pharmacovigilance offices
  • Creation of safety documents helpful to support business
  • Presentation to top management to explain pharmacovigilance requirements and challanges
  • On behalf of QPPV, verification of affiliate SOPs and working instructions
  • SWAT analysis of pharmacovigilance office processes
  • Interaction with Italian Regulators on behalf of non-Italian speaking QPP
  • Technical and scientific translations
  • Creation of a tracking tool shared amongst Pharmacovigilance, Regulatory and Legal offices for licensing agreements
  • Risk-analysis according to Privacy  law requirements
  • Validation of excel file
  • And much more!

Professional development

Lucilla Strano Rossi

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 20 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.