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Strategic Planning for Product Development
International Regulatory Desk Research
Scientific Data Assessment
Product Literature and Readability Testing
Registration
Appeals
Clinical Consultancy
Technical Support in Litigation
Medical Devices
Quality Audits
Publishing and Submissions Management
Training and Seminars
Pharmacovigilance
Licensing
Other Services
Tel: +44(0)1628 530554
Fax:
 +44(0)1628 530559

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spacerQuality Audits

• GMP/GLP/GCP
• ISO 9000

Wainwright Associates has inspectors available to undertake audits of facilities to ensure compliance with the necessary quality standards. Where an official inspection by a regulatory authority is scheduled, a pre-audit by one of our inspectors, using the same criteria, can help identify and resolve any issues which would lead to a negative outcome. Formal, detailed reports are provided for all inspections.

We can perform GMP audits of companies’ own factories or those of contract manufacturers or GLP or GCP audits for CROs or other subcontracted testing facilities. For medical device companies, audits to ISO 9000 or QSR can be undertaken.

We are able to conduct audits worldwide.