Charnley Nickols Associates Ltd.
- United Kingdom
- Human Medicines
- Service category
- GCP audit services, Quality management services
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All our services are customised to meet the individual client's needs. They are informed by our experience of common inspection and audit findings and knowledge of acceptable and practical solutions.
We specialize in:-
- Independent Clinical Assurance (Audit)
- Quality management
- Good Clinical Practice
- Good Pharmacovigilance Practice
GCP and PV Inspection Preparation
- Mock inspections
EU and EMA, UK, FDA, Japanese, International
GCP and PV Audits
System, study specific, CRO, site, in-house (sponsor and marketing authorization holder), clinical report (all stages from CRF, through database, data listings, data summaries, statistics to final clinical report)
- Experience of over 400 audits throughout the World to date
SOP Drafting and Systems Advice
Global, international, corporate, local, departmental and cross-functional
“For cause” investigations and expert witness services
Fully confidential and diligent and prompt services
Auditor training (individual or group) with optional mentoring, inspection training (sponsor, CRO and investigational site staff).
Advice on GCP and PV and all related issues
Telephone, internet correspondence and conferencing and internationally by direct contact through meetings, congresses and training activities.
These are a matter for specific quotation.
We charge a daily rate exclusive of VAT and reasonable (agreed) expenses.
We also charge a reduced hourly rate for travel time.
Our contractual terms will be supplied in relation to specific work proposals.
Approvals, Certificates, Authorisations
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