Digital Innovation
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 The pharmaceutical industry is still largely relying on established, but increasingly outdated, systems and methodologies that were efficient many years ago yet now prove to be a limiting factor in innovation and growth.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 pharma technology-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 realize real, immediate and lasting benefits for our clients – we call this SMARTPHLEX.
Regulatory
Safety
Quality
Statistics
Scientific
Regulatory
A Regulatory Intelligence system for managing officially published Health Authority guidelines, combined with our own experience and recommended best practices.
A Regulatory Information and Process Management system for managing the workflow of regulatory submissions from the planning phase through to submission and archive.
A simple to use ‘plug-in’ tool for Microsoft Word, automating selected existing document processing functionality.
An intelligent system to support the maintenance of medical product information e.g. packaging and patient leaflets.
A smart tool which assesses a company’s readiness and determines their state of compliance for the EU Medical Device Regulation effective in May 2021.
Safety
Application for processing and screening case safety reports of adverse reactions to medicinal products.
Database that tracks pharmacovigilance agreements between clients and third-parties.
A web-based solution for global and local literature monitoring and screening.
Quality
Management of data related to the use of excipients (inactive ingredients) in the manufacturing of medicinal products.
A smart tool which assesses a company’s readiness and determines their state of compliance for the EU Medical Device Regulation effective in May 2021.
Statistics
Software for the validation of physicochemical method such as LC, GC, EC, AAS, titration, UV.
Software dedicated to the evaluation of the long-term stability of your product and to the determination of its shelf life.
Software dedicated to the validation of bioassays such as ELISA, RIA, parallel line, parallel curve, slope-ratio and microbiological assays, qPCR.
Software dedicated to assess if a method can be transferred from a “sender” lab to one or several “receiver” labs according to the tolerance interval approach.
Software dedicated to facilitate report generation in line with all kinds of guidelines and authority (EMA/FDA/MHLW) expectations.
Scientific
Utilizing our strategic and clinical expertise to drive efficiency gains during the earliest phase of development
PharmaLex continually engages with Key Opinion Leaders and scientific experts across the industry to identify opportunities where technology could lead to faster market approval or automated post-market surveillance. Twice nominated by CPhI for our innovative use of technology, we consider this approach to be essential in future proofing our industry.
Our PharmaLex.perts are currently working on developing a number of exciting solutions to bring cutting edge technology to early phase activities. Once tested we will launch them here, so watch this space!
Resources
Whitepaper:
What is preventing us from providing electronic product information and how industry can support the wider ePI project?
Survey:
Disruptive Technologies in Life Sciences (DTLS) consortium – annual survey results