Practical support for GMP and regulatory compliance.

Neuwert Solutions helps organisations assess, prepare for and meet pharmaceutical GMP and regulatory requirements.

Services

Consultancy as per guidelines
Guidance on meeting the requirements of applicable regulatory and GMP guidelines across your site, systems and documentation.
Gap analysis
A structured comparison of current practices and documents against applicable requirements, to show where gaps exist.
QMS evaluation
A review of your quality management system, including its procedures, records and controls.
Mock inspection
A simulated regulatory inspection that shows how a site may be viewed by an inspector, so it can prepare in advance.
Due diligence
A compliance-focused assessment of a site, supplier or partner ahead of a commercial or quality decision.
Validation
Documented evidence that processes, equipment, systems or methods consistently perform as intended.
GMP and regulatory compliance
Support in establishing and maintaining compliance with GMP and applicable regulatory requirements.
GMP audit
An examination of a site, system or supplier against GMP requirements, with findings documented in a report.

Regulatory discipline
Work measured against the guidelines and requirements that apply to your site.
Clear documentation
Findings and recommendations written down in a form you can act on.
Honest assessment
Gaps reported as they are found, not softened.

Neuwert Solutions offers consultancy, audit and compliance services. Further company information will be published as it is confirmed.

Tell us what you need reviewed or supported and we will respond to your enquiry.