Quality, Regulatory and Clinical Consultancy

What Quality, Regulatory and Clinical Consultancy does

Quality, Regulatory and Clinical Consultancy ("QRCC," trading as QRC Consultants Ltd, Companies House No. 7804554) is a UK-based specialist consultancy founded in 2010 and headquartered in St Ives, Cambridgeshire, with a registered office in Royston, Hertfordshire. The firm provides quality assurance, regulatory affairs, and clinical trial support services to biotechnology and pharmaceutical companies, with a stated focus on early-stage clinical development from first-in-clinic through Phase IV. Service lines are organized into three interconnected practice areas: (i) QA and Regulatory Compliance, including Quality Management System (QMS) set-up and maintenance, SOP writing, vendor and systems audits (GCP/GCLP), clinical trial QA audits, and agency inspection readiness; (ii) Regulatory Affairs, covering ad hoc regulatory queries, due diligence, agency meeting briefing documents, orphan drug designation applications (EU and US), and Clinical Trial Authorisation applications; and (iii) Clinical Trial Support, including Phase I study management and monitoring, Trial Master File (TMF) set-up/management/closeout using Veeva Vault, essential document writing (protocols, IBs, CSRs, Informed Consent), CRO selection and oversight, feasibility studies, and bespoke GCP training.

The company monetises primarily through professional services engagements with biotechnology and pharmaceutical sponsors, complemented by a free monthly regulatory bulletin and paid virtual training seminars (e.g., £250 plus VAT per attendee for ICH GCP E6 Revision 3 sessions). An affiliated entity, QRC Ireland ("QRCI"), provides EU Legal Representative services to non-EU sponsors — a statutory requirement under EU clinical trial rules — extending QRCC's addressable market into US and APAC clients running trials in EU Member States. The team comprises approximately 10 named senior professionals (Directors, Principal Consultants, Senior Consultants, Clinical Project Managers) with individual industry tenure of 11-29+ years, holding advanced degrees and memberships in professional bodies such as TOPRA, RQA, ICR, EMWA, and RPS. Geographic focus is the UK and EU, with stated reach extending to North America and global Phase I commercial clinical trial units. QRCC is privately held with no disclosed external investment, parent company, or subsidiaries of substance, and operates with a small leadership team (Sarah Nicholson, PhD, and Alex Gage as founding Directors).

Name

Quality, Regulatory and Clinical Consultancy

Legal name

QRC Consultants Ltd

Website

https://qrcc.co.uk

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

QRCC is a UK-based specialist consultancy providing quality assurance, regulatory affairs, and clinical trial support services — including QMS setup, GCP audits, and Veeva Vault-based Trial Master File management — to small and mid-sized biotech and pharmaceutical sponsors conducting early-stage clinical trials in the UK, EU, and North America.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory & Quality Consultancy

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Consulting Services (8742), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

akta.pro secondary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

Keywords

• Regulatory affairs consulting
• GCP quality assurance
• Clinical trial management
• Pharmaceutical audit services
• Biotech regulatory compliance

Headquarters

HQ city

Saint Ives

HQ country

United Kingdom

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Infrastructure, Technology or R&D

Revenue model

1. Consulting Services: Professional consultancy services including QA & Regulatory Compliance, Regulatory Affairs support, and Clinical Trial Project Management for biotechnology and pharmaceutical companies.
2. Training Seminars: Bespoke training seminars on regulatory procedures and ICH GCP E6, priced at £250 plus VAT per session.
3. Monthly Regulatory Bulletin: Monthly regulatory newsletter and quarterly newsletter subscription service for keeping clients updated with changes in the regulatory environment.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

QRCC is a UK-based consultancy providing quality assurance, regulatory affairs, and clinical trial support services to biotechnology and pharmaceutical companies undertaking clinical drug development. Its core offerings include Quality Management System (QMS) setup and maintenance, SOP writing, GCP/GCLP vendor and clinical trial QA audits, GMP/GDP audits, agency inspection readiness support, regulatory consultancy (including orphan drug designation and CTA applications), EU Legal Representative services through partner QRC Ireland, and clinical trial project management, monitoring, and Trial Master File management (using Veeva Vault).

Product overview

QRCC offers a unified consultancy service structured around three interconnected practice areas: Quality Management Systems and QA/Regulatory Compliance, Regulatory Affairs, and Clinical Trial Support. Quality services include QMS setup and maintenance, SOP writing, GCP/GCLP vendor and systems audits, clinical trial QA audits, and agency inspection readiness. Regulatory Affairs covers consultancy, technical document preparation, orphan drug designation applications, and EU Legal Representative services via QRC Ireland. Clinical Trial Support encompasses project management, monitoring, Trial Master File management (using Veeva Vault), essential document writing and review, CRO oversight, feasibility studies, and bespoke GCP training. The portfolio functions as a coordinated suite supporting early-phase biotechnology and pharmaceutical clinical development from first-in-clinic through Phase IV.

Differentiator

Problem solved

Functional benefit

Products and services

• Quality Management Systems (QMS) Support Setup, maintenance, and periodic management of Quality Management Systems for clinical development programmes, including internal system audits, SOP gap analysis, and ongoing QMS oversight aligned with GCP and national/international regulatory requirements for biotechnology and pharmaceutical sponsors.
• SOP Writing Preparation, review, and maintenance of standard operating procedures and associated forms and templates for clinical development activities.
• Vendor and Systems Audits (GCP/GCLP) Comprehensive auditing services covering Clinical CROs, data management and statistical analysis services, pharmacovigilance services, clinical laboratory bioanalysis services, Phase I unit audits, IMP packaging, labelling and distribution services, and computer system validation assessments.
• Clinical Trial QA Audits Audit services for clinical trials including TMF audits, GCP investigator site audits globally, Phase I study audits, and essential document QC, including audits of trials with Advanced Therapy Investigational Medicinal Products (gene therapies and stem cells).
• Agency Inspection Readiness Preparation services including inspection-readiness training, mock inspections with mock interviews, investigator site preparation, and inspection report response support.
• Regulatory Consultancy Support Ad hoc regulatory queries, regulatory due diligence, and practical support in preparing and reviewing key documents as an integral part of the client's product development team, including keeping clients updated on changes in the regulatory environment.
• Technical Document Preparation and Review Preparation and review of technical documents including agency meeting briefing documents and minutes, orphan drug designation applications (EU and US), and CTA applications.
• EU Legal Representative Services Legal representative services for non-EU sponsors of clinical trials in the EU, facilitated through QRC Ireland (QRCI), a statutory requirement where the Sponsor is not established in the EU; includes regulatory advice on European procedures.
• Clinical Trial Project Management Project management of early phase clinical trials including healthy volunteer studies at Phase I commercial clinical trial units globally, hospital-based clinical trials at UK centres, study setup, maintenance and closeout including REC and HRA management, and vendor selection and management.
• Early Phase Clinical Trial Monitoring Selection, initiation and monitoring of commercial Phase I units globally and hospital sites in the UK for clinical trials.
• Trial Master File (TMF) Management Electronic and paper TMF set-up, management and closeout services, utilising Veeva Vault, a cloud-based Content Management System designed to support management of essential trial documentation.
• GMP and GDP Audits Auditing services to ICH Q7, GMP, and GDP standards covering Active Pharmaceutical Ingredient (API) manufacturers, raw material suppliers, packaging suppliers, contract manufacturing, packaging and labelling facilities, and storage and distribution facilities.
• Essential Document Writing and Review Writing and review of clinical trial protocols, Investigator Brochures, Clinical Study Reports, Informed Consent documents, and EudraCT and Clinicaltrials.gov data upload.
• Interim Clinical Project Management CRO selection, CRO oversight including co-monitoring of CRO-managed trials.
• Feasibility Studies Potential Investigator Questionnaires and tailored interviews for clinical trials to help manage projects.
• GCP and Regulatory Environment Training Bespoke training in GCP and the clinical trial regulatory environment.
• Monthly Regulatory Bulletin and Training Seminars A monthly digest and newsletter keeping clients up to date with changes in the regulatory environment, alongside practical implementation seminars on topics such as ICH GCP E6 Revision 3 (priced at £250 plus VAT per attendee for virtual sessions).

Quantifiable outcome

• Ensures compliance with GCP and national/international regulatory requirements for clinical trial conduct
• +1 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• QRC Ireland (QRCI)coreStrategic or Co-development PartnerQRC Ireland (QRCI) is QRCC's recommended partner for providing EU Legal Representative services to non-EU companies planning to conduct clinical trials in EU Member States. As the statutory requirement where the Sponsor is not established in the EU, QRCI acts as Legal Representative and keeps sponsors updated with changes in the regulatory environment for clinical trial conduct. QRCI also provides ad hoc regulatory advice on European procedures.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Arriello: Arriello is a specialist QA, regulatory and pharmacovigilance consultancy serving biotech and pharma across Europe. Closely comparable to QRCC in scope (QMS, audits, regulatory affairs) and target client profile (small/mid biotech).
• Boyds: Boyds is a UK-based regulatory consultancy providing scientific and regulatory advice to biotech and pharma, including ATMPs. Direct comparable in service mix (regulatory affairs, clinical trial support) and UK/EU client focus.
• Voisin Consulting Life Sciences: Voisin Consulting provides regulatory, clinical, and quality consulting to life sciences companies globally. Overlaps directly with QRCC's regulatory affairs, clinical trial support, and quality management offerings, especially for cell and gene therapy sponsors.
• NDA Group: NDA Group is a European-headquartered regulatory and quality consulting firm serving pharma and biotech. Direct overlap with QRCC in providing QA, regulatory affairs, and clinical development support to small and mid-sized biotech sponsors in Europe.
• TMC Pharma Services: TMC Pharma is a regulatory and clinical consultancy supporting biotech in Europe. Comparable in providing early-phase clinical, regulatory, and quality services to small/mid-sized biotech, similar to QRCC's positioning.

Broad incumbents

• PharmaLex (Cencora): PharmaLex (now part of Cencora) is a large global regulatory and consulting services provider to pharma. Overlaps with QRCC in QA, regulatory affairs, and clinical consulting, but operates at much greater scale and with broader geographic reach.
• Clinipace Worldwide: Clinipace is a mid-sized global CRO providing regulatory, clinical, and quality services to biotech. Comparable service mix to QRCC but with broader geographic footprint and a more enterprise-oriented go-to-market.
• ICON plc: ICON is a leading global CRO offering integrated clinical, regulatory, and quality services. Provides overlapping capabilities to QRCC but at significantly greater scale and via bundled enterprise engagements.

Others

• Parexel International: Parexel is a major global CRO with established regulatory and clinical consulting services. Competes with QRCC for QA/regulatory work but at much larger scale and as part of broader full-service CRO offerings.

Emerging players

• DG Analytical & Clinical Consulting: DG Analytical is a smaller specialized regulatory and clinical consultancy serving biotech. Comparable boutique positioning to QRCC in QA and regulatory services, with similar focus on small/mid biotech sponsors.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/qrcconsultants

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Quality, Regulatory and Clinical Consultancy