PQE is a Contract Quality Organisation and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 4,000 projects world wide and now serve our Clients from offices in Italy, Spain, Switzerland, LATAM, the Middle East and China. As an international company we have experience working in more than 15 languages and have an excellent history of supporting small, medium and large size companies exceed compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA and other local authorities.
PQE offers turn key quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.
As a turn key solution provider we offer the following services:
Computer System Validation
Computer System Validation has been PQE’s core business since its foundation in 1998. We have an unmatched track record of providing our clients with strategy and execution support with their FDA / EMA / WHO / TGA / SSA/ SFDA /ANVISA / INVIMA and other Local Regulatory Body compliance projects. Our multidisciplinary team, which has extensive years of experience, enables us to support our clients in turnkey validation projects for all types of computerized systems: management information systems, systems from a manufacturing area and applications used in Laboratories.
Regulated ICT Solutions
Regulated IT Solutions consists of a multidisciplinary team of professionals with a background in electronic engineering, software development, systems integration and information technology. We are able to offer a broad spectrum of scalable services, thanks to our proven experience in the field of IT solutions, infrastructure qualification and computer systems validation for life science companies.
Qualification & Engineering
Our service excellence is achieved through an interdisciplinary teamwork among engineers and technicians, who have a unique integrated knowledge in process engineering, information technology and quality in regulated environments. Due to our complete in house instruments park and our robust expertise in Pharmaceutical, Biopharmaceutical and APIs field, we can provide turnkey qualification solutions for process equipment and utilities qualification, based on the latest technologies and regulatory requirements. This allows us to focus on minimizing compliance related risks and costs for our client
Regulated Lab Solutions
PQE has multidisciplinary and specialized teams, which include engineers, chemists, biologists and IT experts. Our aim is to support laboratories in the food and drugs industries, with independent and fully specialized services providing accurate and reliable analytical data in a fully regulated environment
PQE supports customers through the entire drug regulatory lifecycle, providing a full range of regulatory activities. Our service begins with the development of the regulatory strategy and concludes with the editing, amendment and submission of the necessary documents of the dossier. Due to the expertise of our consultants, fully electronic submissions for the EU / USA, along with paper submissions are handled in the fastest and most professional manner, while ensuring that dossiers are compliant to the strictest and evolving regulations.
GCP & PV Compliance
The development of a GCP Quality Management System (plan and resources) is the basis to promote and support compliance, while minimizing regulatory risk. PQE proposes the implementation of a GCP quality strategy that will adapt to the Client’s requirements and support an effective and compliant conduction of clinical trials. This monitoring process ensures adequate protection of subjects, along with the quality and integrity of the clinical study data itself. In order to deliver leading GCP services to PQE clients, our consultants practice the most innovative Quality by Design and Quality Risk Management approaches related to clinical studies. PQE ensures a strong emphasis on the concepts of good quality control, with adequate documentation throughout the delivery of a clinical trial by investigators and throughout all data management processes leading to a regulatory submission.
In 2010, Regulatory Authorities raised the bar of compliance of the Pharmacovigilance System and an increasing number of countries are now performing routine regulatory inspections targeting Pharmacovigilance. An established quality system that is adequate and effective for performing pharmacovigilance activities has become a regulatory requirement. PQE can support the implementation of a pharmacovigilance quality system, starting from the compliance assessment of “AS-IS” scenario, which involves document editing and the quality system deployment at corporate or local level. The focus of PQE’s support is the compliance with applicable regulation as well as the suitability of the system to the company needs.