One of our core specialties lies in EU GMP-ready facilities. We understand the critical importance of meeting the stringent standards set by the European Union to ensure the highest levels of quality, safety, and compliance. Our expertise in EU GMP regulations allows us to create facilities that are tailored to meet these rigorous requirements.
Our GMP Consulting and Regulatory Compliance Service is all-encompassing. Typically, our service begins with a GMP Compliance or Mock Inspection, which serves as a foundational step. During this process, we pinpoint areas where current compliance standards may require improvement. The resulting Audit Report provides a clear overview of the disparities between existing compliance status and the stipulated requirements outlined in various legislations and guidance documents. Furthermore, it contains actionable recommendations to bridge these gaps.
In addition to this comprehensive analysis, we offer support for the practical implementation of these recommendations. This can include tasks such as drafting Standard Operating Procedures (SOPs), Validation Master Plans, and other essential compliance documents to ensure a seamless transition towards improved compliance standards.