(01 June 2017 – Rome, Italy) – seQure Life Sciences today announced the official launch of a new entity and brand name. Formally known as PM Clinical, seQure Life Sciences is now exclusively a niche provider of pharmacovigilance, quality assurance and regulatory services for the life sciences industry striving to meet the outsourcing demands of this sector which includes having the right resources to ensure compliance both pre and post-market.
seQure Life Sciences boasts a team of experts and industry-leading talent in pharmacovigilance, quality and regulatory affairs by securing compliance to ICH, GCP and regulatory authority legislation and guidelines.
The company is structured around four main business lines:
- Pharmacovigilance: case processing and reporting, signal detection and safety system implementation
- Quality Assurance for GxP and PVQA
- Computer System Validation
- Regulatory Affairs: submissions of Marketing Authorization Applications and Clinical Trial Applications
seQure is led by Paolo Morelli, CEO, who is also the Chairman of PM Holding. Other senior management figures in the company include Daniela Marcozzi, Vice President, Strategic Account Management, who also carries over 20 years of experience in quality management systems in the life sciences sector, Antonella Ursini, Quality Management Director with decades of experience in the large pharma sector, and Stefania De Santis, Pharmacovigilance Director and EU Qualified Person for Pharmacovigilance (QPPV).
Paolo Morelli, CEO, said, “we are proud to add seQure to our diversified portfolio of companies operating in the life sciences sector. There is a growing market demand for leading knowledge experts on safety, quality assurance and regulatory affairs in the life sciences sector to ensure compliance across all areas of GxP. We have assembled one of the best teams in Europe in terms of expertise, experience and comprehension of industry standards and regulations to give customers peace of mind in these key areas of the drug and device life cycle”.
The new company is part of PM Holding, a life sciences holding group that also includes CROS NT (full service CRO) and ARITHMOS (life sciences technology).
The company has its operational office based in Rome, Italy.
seQure is a niche services provider operating in the Life Sciences sector. seQure provides expert pharmacovigilance, quality management and assurance, regulatory and computer system validation solutions to drug and device companies to help them meet regulatory requirements. seQure services are provided as consultancy, as projects or in a functional service provision model. The company strives to meet specific needs of clients in the following sectors: pharmaceutical, biotechnology, medical device, academic institutions and associations as well as CROs (Contract Research Organizations) and Service Providers.
In order to achieve the best results, seQure creates a team with over 25 years of experience in pharmacovigilance and quality assurance sector.