Quality, Regulatory and Clinical Consultancy
QRC Consultants Ltd (QRCC) is a specialist consultancy supporting regulatory compliance, quality management, and clinical trial services for biotechnology and pharmaceutical companies. They focus on quality systems management, regulatory affairs, clinical trial support, and auditing services, with a mission to support clients through all phases of clinical development and regulatory processes. QRCC also actively participates in industry events, provides expert guidance, and has a history of growth and milestones including a management buyout and celebrating 10 years in business.
Industries
Nr. of Employees
small (1-50)
Quality, Regulatory and Clinical Consultancy
Saint Ives, Cambridgeshire, United Kingdom, Europe
Services
Set up proportionate Quality Management Systems and SOPs for Sponsors, provide ongoing QA oversight and keep systems aligned with regulatory changes.
Provision of clinical research consultants and CRAs to monitor trials, manage Trial Master Files and support early-phase trial operations.
Conduct audits across manufacturing and supply chain (APIs, raw materials, packaging, contract manufacturers, storage/distribution) and perform clinical QA audits including ATIMP-specific assessments.
Practical regulatory advice, preparation and review of documents for regulatory procedures and support for agency interactions throughout clinical development.
Support Sponsor oversight responsibilities including CRO/ vendor selection, oversight, documentation and governance aligned to current ICH guidance.
Facilitate provision of an EU-based legal representative for non-EU Sponsors to meet statutory requirements for EU clinical trials and provide ad hoc European regulatory advice.
Set up proportionate Quality Management Systems and SOPs for Sponsors, provide ongoing QA oversight and keep systems aligned with regulatory changes.
Provision of clinical research consultants and CRAs to monitor trials, manage Trial Master Files and support early-phase trial operations.
Conduct audits across manufacturing and supply chain (APIs, raw materials, packaging, contract manufacturers, storage/distribution) and perform clinical QA audits including ATIMP-specific assessments.
Practical regulatory advice, preparation and review of documents for regulatory procedures and support for agency interactions throughout clinical development.
Support Sponsor oversight responsibilities including CRO/ vendor selection, oversight, documentation and governance aligned to current ICH guidance.
Facilitate provision of an EU-based legal representative for non-EU Sponsors to meet statutory requirements for EU clinical trials and provide ad hoc European regulatory advice.
Expertise Areas
- Clinical trial management (Phases I–IV)
- Quality management systems and GCP compliance
- Regulatory affairs and regulatory submissions
- GMP/GDP auditing and supply chain compliance
Key Technologies
- Cloud-based electronic Trial Master File (eTMF) platforms
- Quality Management Systems (QMS)
- Clinical monitoring methodologies
- GMP/GDP audit frameworks
News & Updates
QRCC’s Director and Head of Clinical Operations, Alex Gage, is appointed joint Chair of the CCRA’s Regulatory Affairs Working Group
QRCC’s Alex Gage was appointed joint Chair of the CCRA’s Regulatory Affairs Working Group, which supports industry interests and discusses regulatory challenges.
QRCC upcoming meeting attendance
QRCC will attend several conferences in 2023 including the OBN Biotrinity meeting and the One Nucleus On Helix congress.
QRCC Sponsor Oversight Virtual Seminar
A virtual seminar focusing on sponsor oversight responsibilities in clinical trials, scheduled for 30th April 2024.
QRCC Seminar 30th November 2023
In-person seminar on sponsor oversight responsibilities, held in St Ives, Cambridgeshire, with networking opportunities.
QRCC’s Director & Head of Clinical Operations, Alex Gage, will attend the EUCROF24 congress in Prague on 19-20 February 2024.
Alex Gage will connect with colleagues across Europe to discuss QRCC’s services in quality, regulatory, and clinical operations.
QRCC is 10 years old!
Celebrated 10 years in business on 2nd April 2022, supporting clients and employing 18 staff across various functions.
QRCC’s Director and Head of Clinical Operations, Alex Gage, is appointed joint Chair of the CCRA’s Regulatory Affairs Working Group
QRCC’s Alex Gage was appointed joint Chair of the CCRA’s Regulatory Affairs Working Group, which supports industry interests and discusses regulatory challenges.
QRCC upcoming meeting attendance
QRCC will attend several conferences in 2023 including the OBN Biotrinity meeting and the One Nucleus On Helix congress.
QRCC Sponsor Oversight Virtual Seminar
A virtual seminar focusing on sponsor oversight responsibilities in clinical trials, scheduled for 30th April 2024.
QRCC Seminar 30th November 2023
In-person seminar on sponsor oversight responsibilities, held in St Ives, Cambridgeshire, with networking opportunities.
QRCC’s Director & Head of Clinical Operations, Alex Gage, will attend the EUCROF24 congress in Prague on 19-20 February 2024.
Alex Gage will connect with colleagues across Europe to discuss QRCC’s services in quality, regulatory, and clinical operations.
QRCC is 10 years old!
Celebrated 10 years in business on 2nd April 2022, supporting clients and employing 18 staff across various functions.