GxP Auditing and Consulting for regulatory compliance
The importance of auditing and consulting in regulated environments
In the pharmaceutical, biotech, and healthcare industries, compliance with GMP, GDP, GLP, GCP, and GVP standards is critical to ensure the quality, safety, and conformity of products and processes. Effective auditing helps identify regulatory gaps and ensures that operations meet the requirements set by authorities like the EMA and FDA.
Benefits of our auditing and consulting services
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Guaranteed regulatory compliance
We ensure your company meets the requirements of EMA, FDA, and other authorities.
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Detection and correction of deviations
We identify risks and help correct them to prevent regulatory penalties.
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Process optimization
Enhancing operational efficiency and product quality.
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Ongoing support
Our consulting team offers tailored guidance to meet each client’s specific needs.
Ensure regulatory compliance with our GxP auditing and consulting services. Comply with GMP, GDP, GLP, GCP, and GVP standards while optimizing operational quality and safety.
Our GxP auditing services
We have a team of experts in both internal and supplier audits, providing support in:
- Regulatory compliance (GMP, GDP, GLP, GCP, GVP)
Assessment of your organization’s adherence to current regulations. - Internal and supplier audits
Reviewing processes to ensure quality and traceability. - Audits of IT and cloud service providers
Validating digital solutions under GxP compliance requirements. - Audits of specific regulatory requirements
Evaluation of Data Integrity, EU Annex 11, and 21 CFR Part 11 to ensure data integrity and regulatory adherence. - Clinical trial audits (GCP)
Reviewing the quality and management processes of clinical studies.
GxP Consulting Services
We offer specialized consulting to ensure the correct implementation and maintenance of good practices across regulated industries:
- Support for good practices
Assistance in the proper application of GxP standards across all production and quality control areas. - Quality System development
Designing and implementing strategies to ensure process quality and compliance. - GAP assessments
Identifying and correcting deviations in systems, processes, and documentation. - Support for IT system developers
Advising developers to ensure their solutions comply with applicable regulations.
