Quality Management That Ensures your Compliance

We ensure your trials meet the highest GCP & regulatory standards, with processes built for accuracy, compliance, & confidence. Our team delivers the systems, audits, & oversight to make that possible. 

This isn’t an add-on service—it’s at the core of everything we do. 

 
Talk to a Quality Expert

Our Services

Gap Analysis of QM Systems

We review your existing quality management systems (QMS), SOPs, & processes to identify gaps or weaknesses & provide clear, actionable improvements. 

  • Identify compliance gaps 
  • Recommend pragmatic fixes 
  • Build a roadmap for stronger systems 

SOPs & Controlled Documents

We create or refine SOPs, templates, & further controlled documents that are precise, practical, & easy for teams to follow. 

  • Review & update existing SOPs 
  • Develop new templates & processes 
  • Provide documentation that balances compliance with usability 

Quality Assurance Through Audits

We conduct independent audits that ensure your trial is 'quality-ready'. 

  • Investigational site audits 
  • Service provider qualification audits 
  • System audits of your departments or cross-functional processes 
  • Flexible: use our own standards or your SOPs

Gap Analysis of QM Systems

We review your existing quality management systems (QMS), SOPs, & processes to identify gaps or weaknesses & provide clear, actionable improvements. 

  • Identify compliance gaps 
  • Recommend pragmatic fixes 
  • Build a roadmap for stronger systems 

SOPs & Controlled Documents

We create or refine SOPs, templates, & further controlled documents that are precise, practical, & easy for teams to follow. 

  • Review & update existing SOPs 
  • Develop new templates & processes 
  • Provide documentation that balances compliance with usability 

Quality Assurance Through Audits

We conduct independent audits that ensure your trial is 'quality-ready'. 

  • Investigational site audits 
  • Service provider qualification audits
    System audits of your departments or cross-functional processes 
  • Flexible: use our own standards or your SOPs 

How We Work

  • 01Assess

    Independent gap analysis of existing QM systems & documentation.

  • 02Strengthen

    Refine SOPs & processes in alignment with GCP & regulatory standards.

  • 03Support

    Prepare your systems for independent audits by external parties, & accompany you through inspections with proactive guidance.

Why Sponsors Choose Us

Regulatory Confidence

Deep knowledge of GCP & evolving EMA/FDA expectations ensures your systems stand up to inspection.

Operational Fit

We design SOPs & QM frameworks that integrate into your existing workflows, not around them.

Risk Reduction

Early gap detection & pragmatic solutions help you avoid findings, delays, & costly remediation.

Compliance & Training

GCP, ICH, EMA compliance
RQA/GQMA certified

Your benefits

  • Higher regulatory compliance 
  • GCP compatible processes for inspection readiness 
  • Confidence for internal teams & stakeholders 
  • Process-focused approach with fresh & external eye

Ready to Strengthen Your Process Quality?

Call Christoph Ortland directly right now or write us an email.

Christoph Ortland
+49 1520 921 89 32
info@forschungsdock.de

Ready to Strengthen Your Process Quality?

Call Christoph Ortland directly  on +49 (0) 1520 921 89 32 or write us an email.

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