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Sourcing Inquiry Logo Charnley Nickols Associates Ltd.

Charnley Nickols Associates Ltd.

Regions
Worldwide
Countries
United Kingdom
Size
50-100
Specialty
Human Medicines
Service category
GCP audit services, Quality management services
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Key services

Services

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
  •  Training
  •  Advice

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

Training

 

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.


Rates

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.

 

Contracts

Our contractual terms will be supplied in relation to specific work proposals.

Approvals, Certificates, Authorisations

  • FDA

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