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Regulatory affairs


Compliance & inspection readiness

Pope Woodhead has significant experience in ensuring that organisations are compliant and inspection-ready. If deficiencies are identified, we will assist with the development and implementation of process improvements and practical training.

We offer:

Assessment of quality assurance measures (e.g. PSUR quality and 7/15 day reporting)
System assessment
Compliance with post-marketing safety commitments
Process optimisation
Training.

Recent projects:

Quality process assessment for a biotech client
Compliance with risk management commitments and post-marketing implementation within a pharma company.

 

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