Contract QP Services
you can trust
At BioChem QP Consulting, we pride ourselves on providing
services that protect your compliance reputation, build
productive relationships both within your company and with its
partners, and achieve our shared objectives of realising
product quality, drug availability, regulatory compliance, and
patient safety in a commercial or clinical trial setting - to help
give you peace of mind that your GMP compliance is in safe
hands (so you can relax when you’re next on the beach…)
What we bring to you
We bring genuine depth of product experience, gained on the front line from over 20 years of continuous batch-releasing QP activity as a permanent provisions EU/UK QP, with eligibility attained at fist assessment through the UK ‘QP viva’ examination process in 2006, at the Royal Society of Chemistry. We’ve worked as QP with solid oral dosage, high speed commercial packaging lines, small scale clinical tral packaging (including randomised / blinded supplies), live viral vaccines, cell and virus banks, mAbs, ‘Specials’, sterile fill / finish injection vials and pre-filled syringes, lyophilised injections, setting up of QP importatation sites into UK / EU including UK QP oversight role for IMPs, and multiple ATMPs including viral vector gene therapries, hESCs, various T-cell therapies, CAR-T vectors, and CRISPR-Cas9 products. In addition, since 2010 we have performed >150+GMP site audits in UK, EU, US, India, China, Canada, Switzerland, etc. - providing a broad perspective on different approaches to achieving GMP compliance, keeping us abreast of industry trends and best practices
We have worked as Contract QP with global clients, across multiple GMP
compliance requirements, for over 15 years…
Participating in over 30 regulatory inspections (MHRA, FDA, HPRA, EMA, TGA, PMDA, ANVISA, GCC, etc.) >150 supplier audits (API, biological DS, solid oral dosage, sterile fill / finish, lyophilisation, ATMP sites) completed with 100% client satisfaction
What’s with all the beaches?
BioChem QP Consulting is based in Glasgow, Scotland UK; we also occasionally work from Mallaig, on the beautiful coast of Lochaber in the ‘Rough Bounds’ of the West Highlands. This area has some of the most fantastic landscapes and beaches in the UK (these are my own photos - not stock ones!), and we don’t like being away from it for too long! That’s why our Contract QP offering is aimed specifically at companies within commuting distance of Glasgow (the accompanying picture shows our current company vehicle fleet). We cover the Glasgow - Edinburgh Central Belt, including Stirling and Dundee areas - basically anywhere we can reasonably commute to on train and bike from Glasgow. We firmly believe that regular on-site attendance is critical for Contract QP roles. Obviously for audits and other short term assignments we will travel anywhere, but this is our base and we like it here.
Address
BioChem QP Consulting Ltd. Clyde Offices 48 West Regent Street Glasgow, G2 1BP Scotland, UKWe’re in it with you
We are not one of those consultancies that swoop in on your organisation, leaving you 3 months later with just some powerpoint slides and a hefty invoice, but no lasting impact. Each of our business relationships over the last 15 years as a contract QP consultancy, has been long-lasting (many for 5-10 years) and productive. Our batch release activities mean we’re there with you when the inspectorate next comes to visit, and our audit activities for QP declarations and general supplier assurance have involved multiple site audits for each client - building up deep understanding and knowledge of their product supply chain - and provision of audit reports in a level of detail, including insight into site culture as well as GMP compliance, that we would want to receive if it were to support our own batch release activities. So again - when the time comes for a break, you can relax on the beach, knowing that we’re in this together and BioChem QP Consulting has your back
Contract QP Services
you can trust
At BioChem QP Consulting, we pride ourselves on providing
services that protect your compliance reputation, build
productive relationships both within your company and with
its partners, and achieve our shared objectives of realising
product quality, drug availability, regulatory compliance, and
patient safety in a commercial or clinical trial setting - to help
give you peace of mind that your GMP compliance is in safe
hands (so you can relax when you’re next on the beach…)
What we bring to you
We bring genuine depth of product experience, gained on the front line from over 20 years of continuous batch-releasing QP activity as a permanent provisions EU/UK QP, with eligibility attained at fist assessment through the UK ‘QP viva’ examination process in 2006, at the Royal Society of Chemistry. We’ve worked as QP with solid oral dosage, high speed commercial packaging lines, small scale clinical tral packaging (including randomised / blinded supplies), live viral vaccines, cell and virus banks, mAbs, ‘Specials’, sterile fill / finish injection vials and pre-filled syringes, lyophilised injections, setting up of QP importatation sites into UK / EU including UK QP oversight role for IMPs, and multiple ATMPs including viral vector gene therapries, hESCs, various T-cell therapies, CAR-T vectors, and CRISPR- Cas9 products. In addition, since 2010 we have performed >150+GMP site audits in UK, EU, US, India, China, Canada, Switzerland, etc. - providing a broad perspective on different approaches to achieving GMP compliance, keeping us abreast of industry trends and best practices
We have worked as
Contract QP with global
clients, across multiple
GMP compliance
requirements, for over
15 years…
Participating in over 30 regulatory inspections (MHRA, FDA, HPRA, EMA, TGA, PMDA, ANVISA, GCC, etc.) >150 supplier audits (API, biological DS, solid oral dosage, sterile fill / finish, lyophilisation, ATMP sites) completed with 100% client satisfaction
What’s with all the
beaches?
BioChem QP Consulting is based in Glasgow, Scotland UK; we also occasionally work from Mallaig, on the beautiful coast of Lochaber in the ‘Rough Bounds’ of the West Highlands. This area has some of the most fantastic landscapes and beaches in the UK (these are my own photos - not stock ones!), and we don’t like being away from it for too long! That’s why our Contract QP offering is aimed specifically at companies within commuting distance of Glasgow (the accompanying picture shows our current company vehicle fleet). We cover the Glasgow - Edinburgh Central Belt, including Stirling and Dundee areas - basically anywhere we can reasonably commute to on train and bike from Glasgow. We firmly believe that regular on-site attendance is critical for Contract QP roles. Obviously for audits and other short term assignments we will travel anywhere, but this is our base and we like it here.
Address
BioChem QP Consulting Ltd. Clyde Offices 48 West Regent Street Glasgow, G2 1BP Scotland, UKWe’re in it with you
We are not one of those consultancies that swoop in on your organisation, leaving you 3 months later with just some powerpoint slides and a hefty invoice, but no lasting impact. Each of our business relationships over the last 15 years as a contract QP consultancy, has been long-lasting (many for 5-10 years) and productive. Our batch release activities mean we’re there with you when the inspectorate next comes to visit, and our audit activities for QP declarations and general supplier assurance have involved multiple site audits for each client - building up deep understanding and knowledge of their product supply chain - and provision of audit reports in a level of detail, including insight into site culture as well as GMP compliance, that we would want to receive if it were to support our own batch release activities. So again - when the time comes for a break, you can relax on the beach, knowing that we’re in this together and BioChem QP Consulting has your back