A4P BIO Providing solutions for life sciences in Biomarkers, Pharmacokinetics, Bioanalysis and Logistics

As experts in biomarkers, bioanalysis, pharmacokinetics, logistics and quality systems management. We at A4P deliver scientifically robust, regulatory compliant, cost effective and value added solutions for the global life sciences sector. Logistic services for time and condition critical material shipments anywhere in the world.

Quality systems consultation and implementation A4P quality system solutions delivers expertise and resource in the implementation, management and oversight of providers, particularly in GCLP/GLP and logistic provider GDP compliance.

Why use A4P to manage outsourced bioanalysis

It may seem counter-intuitive or even wasteful to further outsource an already outsourced activity. After all isn’t outsourcing the way to completely remove your resource and expertise problem by engaging and pay for an end to end service. So why indeed appear to pay twice for what looks like the same thing?

Sponsors outsourcing drug development activities are obliged by regulatory authorities to demonstrate oversight of those activities. The sponsor is judged to be solely responsible for the work and whilst outsourced providers have accountability to the sponsor, this has to be demonstrated, most often by documents and records.

Often, it takes a lot more resource than sponsors first or subsequently realise to actually manage and deliver this oversight. Recent analysis off this area suggests only 1 in 5 sponsors believe they actually completely fund and resources their needs. In our experience, gathered over many years and numerous programs that failing will often lead to issues that are, at best costly to fix at a later date or simply just not possible. This can be especially true in those first critical steps in a regulatory development programme. So, avoiding that consequence can and does protect investments if you are outsourcing bioanalysis, it is critical to ensure that the oversight is performed by people that have expertise and experience in this area.

Using our extensive experience A4P provide the resource, processes and expertise to deliver demonstrable oversight and effective management of outsourced bioanalysis.

Above all we have the ability to action this anywhere in the World from our base in the UK.

For more information please don’t hesitate to contact me

• [email protected] Mob: +44 (0) 7741886507 Office +44 (0) 1304249106