Contract QP Services
you can trust
At BioChem QP Consulting, we pride ourselves on providing
services that protect your compliance reputation, by building
productive relationships within your company and with its
partners, to reach our shared objectives - realising product
quality, drug availability, regulatory compliance, and patient
safety in a commercial or clinical trial setting - giving you
peace of mind that your GMP compliance is in safe and
experienced hands (so you can relax when you’re next on the
beach…)
What we bring to you
We bring genuine depth of contract QP experience, gained 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 importation sites into UK / EU, including UK QP oversight role for IMPs, and multiple ATMP (HCT/P in US) products including viral vector gene therapries, hESCs, various T- cell therapies, ex-vivo CAR-T vectors, and CRISPR-Cas9 products. In addition, since 2010 we have performed >150 GMP site audits in UK, EU, US, India, China, Japan, Canada, Switzerland, etc. for chemical, biological, and ATMP drug substances and products - providing us with a broad perspective on different approaches to achieving GMP compliance, and keeping us abreast of industry / regulatory 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 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 (this picture shows our company vehicle fleet). We cover the Glasgow - Edinburgh Central Belt, including Stirling and Dundee areas - basically anywhere we can reasonably commute to daily 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 provide a friendly, candid, pragmatic, and approachable service, and for non- UK/EU clients we work hard to demystify the requirements of the QP role. Most of our engagements over the last 15 years have been long-lasting (5-10 years), indicating high levels of client satisfaction, and expanding our valuable network along the way. We’ve helped UK CMOs and importation facilities with contract QP services, US biotech clients with ‘QP audits’ around the globe, focussing every more on biologics, steriles, and ATMPs, building on our prior career experience of chemical APIs and more traditional dosage forms. Our routine batch release activities mean we’re up to speed with current inspectorate expectations, 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 industry best practices. We provide comprehensive audit reports, in a level of detail that we would want to receive to support our own batch release activities, including insight into site culture as well as GMP compliance, So again - when the time comes for a well-earned break, you can relax, 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, by building
productive relationships within your company and with its
partners, to reach our shared objectives - realising product
quality, drug availability, regulatory compliance, and patient
safety in a commercial or clinical trial setting - giving you peace
of mind that your GMP compliance is in safe and experienced
hands (so you can relax when you’re next on the beach…)
What we bring to you
We bring genuine depth of contract QP experience, gained 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 importation sites into UK / EU, including UK QP oversight role for IMPs, and multiple ATMP (HCT/P in US) products including viral vector gene therapries, hESCs, various T-cell therapies, ex- vivo CAR-T vectors, and CRISPR-Cas9 products. In addition, since 2010 we have performed >150 GMP site audits in UK, EU, US, India, China, Japan, Canada, Switzerland, etc. for chemical, biological, and ATMP drug substances and products - providing us with a broad perspective on different approaches to achieving GMP compliance, and keeping us abreast of industry / regulatory 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 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 (this picture shows our company vehicle fleet). We cover the Glasgow - Edinburgh Central Belt, including Stirling and Dundee areas - basically anywhere we can reasonably commute to daily 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 provide a friendly, candid, pragmatic, and approachable service, and for non-UK/EU clients we work hard to demystify the requirements of the QP role. Most of our engagements over the last 15 years have been long-lasting (5-10 years), indicating high levels of client satisfaction, and expanding our valuable network along the way. We’ve helped UK CMOs and importation facilities with contract QP services, US biotech clients with ‘QP audits’ around the globe, focussing every more on biologics, steriles, and ATMPs, building on our prior career experience of chemical APIs and more traditional dosage forms. Our routine batch release activities mean we’re up to speed with current inspectorate expectations, 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 industry best practices. We provide comprehensive audit reports, in a level of detail that we would want to receive to support our own batch release activities, including insight into site culture as well as GMP compliance, So again - when the time comes for a well-earned break, you can relax, knowing that we’re in this together and BioChem QP Consulting has your back