Expertise.

Good Laboratory Practice.

Ensure the quality of your non-clinical studies.

Efficient.

Optimization of your laboratory processes for maximum efficiency and accuracy.

Sure.

Ensuring compliance with all GLP regulations and standards.

Transparent.

Detailed documentation and reporting for maximum transparency and traceability.

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How we can support you with Good Laboratory Practice.

Our GLP Consulting Service offers you the optimal solution for specific challenges in the field of non-clinical research and development. From regulatory consulting to the implementation of quality standards and preparation for inspections - we are your partner for success.

  • Support in compliance with GLP guidelines such as 21 CFR part 58, OECD, guidelines 2004/09/EC, Dir 2004/10/EC and German ChemG §19a.
  • Consulting and implementation of GCLP (Good Clinical Laboratory Practice) according to EMA/INS/GCP/532137/2010.
  • Conduct facility, study and process audits to ensure your facilities and procedures meet GLP standards.
  • Data integrity audits according to GCP (REG 534/2014) & GCLP (EMA/INS/GCP/532137/2010).
  • SDV (Source Data Verification) and SDR (Source Data Review) conformity and data integrity assessment.
  • GLP site qualification and training of your employees to ensure that everyone involved knows and can implement the GLP requirements.
  • Preparation for GCP and GCLP inspections to ensure that your studies and processes comply with regulatory requirements at all times.
  • Implementation and evaluation of state-of-the-art concepts for BRAT (Benefit-Risk Action Team) and RBM (Risk-Based Monitoring).

GLP Consulting: Your partner for quality and efficiency.

Our GLP Consulting Service offers you tailor-made solutions for optimizing and monitoring your laboratory processes. We support you in meeting the highest standards of Good Laboratory Practice (GLP) and ensuring the quality of your non-clinical studies.

Efficient processes.

Regulatory security.

Sustainable implementation.

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How we can support you in Good Laboratory Practice.

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