Leading technological innovation

Automation, artificial intelligence (AI) and machine learning are revolutionizing many industries enabling increased productivity, improved quality and enhancing return on investment. The pharmaceutical industry is still largely relying on established, but increasingly outdated, systems and methodologies that were efficient many years ago yet now prove to be a limiting factor in innovation and growth. At PharmaLex we combine our extensive global experience and deep understanding of pharmaceutical lifecycle processes with the development of our cloud-based platform for life sciences automation alongside key partnerships with leading technology vendors. Through our software enabled services we are helping our customers to adopt and take advantage of innovative technologies to drive efficiency gains within their own operations.

Most pharmaceutical companies have the raw ingredients at their fingertips – mass volumes of valuable historical data that can be analyzed to predict future outcomes. At PharmaLex we have the technology, know-how and experience to take these raw ingredients and realise real, immediate and lasting benefits for our customers – we call this Knowledge. Accelerated. Some examples of software enabled service portfolio below.

  • GxP management – orchestration of all global Pharmacovigilance activities within a single cloud solution integrating to existing safety databases and tools
  • Case processing – automated processing and audited screening of incoming E2B(R3) case safety reports for both L2A and MLM scenarios
  • Literature screening – automated monitoring of safety literature outputting CIOMS or E2B compatible safety reports in a quality assured environment
  • Contracts/Agreements – efficient cloud-based management of Pharmacovigilance agreements ensuring all party compliance with safety obligations
  • Holistic solution for automation of regulated processes enabling fast, cost-effective and compliant transition to paperless quality and compliance
  • Risk Assessment Tool for Excipients (RATE)
  • Vendor Metrics – compliance management and risk assessment of GXP vendors
  • Regulatory Intelligence – customized data management solutions and services for Regulatory Intelligence throughout the full product lifecycle
  • Regulatory Operations – expert support and industry partnerships for selection, implementation and operation of end-to-end regulatory systems landscapes including Regulatory Information Management, publishing and archiving
  • Patient Information Management – innovative process automation platform for ensuring global continuity and compliance of patient information and labeling documents for both innovator and generic products
  • Redaction – efficient and compliant anonymization of trial data and documents
  • Early Stage Research – advanced research analytics, insights and statistics as they happen

What our clients say

Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

Leading European Specialist Pharma Company
Head of Medical Writing and Publications

We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.

Small Medium Sized Company, UK
Head of Regulatory Affairs