Support During Regulatory Inspections

 

Pharma & Biotech Consulting offers comprehensive support and representation during regulatory inspections in the GMP, GDP, GLP, and GVP environments. We accompany your company through every phase of the inspection, ensuring that all requirements are met efficiently and professionally. Our service includes preparatory analysis to identify areas for improvement, proactive elimination of identified weaknesses, and active representation during the inspection. Following the inspection, we handle the follow-up of findings by developing and implementing a targeted action plan. We are also available to manage all communication with the relevant authorities to ensure a smooth process.

 

Our expertise and proven methods have been validated through collaboration with authorities such as German regulatory agencies, the US FDA, Swissmedic, MFDS Korea, ANVISA, and AGES. We strictly adhere to current national regulations (AMP, AMWHV, HV), EU guidelines (GMP, GDP, GLP, GVP), FDA requirements (CFR 21 Part 210, 211, 11, 820), and ISO standards (ISO 9000, ISO 13485).

 

Our approach begins with an initial gap analysis to identify potential deficiencies, followed by the implementation of preparatory improvement measures. During the inspection, we stand by your side and provide active support. Afterward, we conduct effective CAPA management for sustainable follow-up. For realistic preparation, we also offer mock audits to optimally prepare your company for the upcoming inspections. With Pharma & Biotech Consulting, you have a reliable partner guiding you through every phase of regulatory inspection.

Comprehensive Assistance According to National and International Standards

 

  • According to national regulations: AMP, AMWHV, HV
  • According to EU guidelines: GMP, GDP, GLP, and GVP
  • According to FDA requirements (CFR 21): Part 210, 211, 11, 820
  • According to ISO standards: ISO 9000, ISO 13485
  • Initial gap analysis
  • Preparatory improvement measures
  • Support during the inspection
  • Follow-up (CAPA management)
  • Mock audits