Regulatory supervision of GMP compliance is crucial for pharma and biotech manufacturers. Based on strong partnerships, we help you find your way through increasingly complex regulatory areas and move you forward.
Your needs determine the nature of the teams we set up. Our GMP compliance and validation experts include former inspectors, ISO auditors and key people in quality and production.
Your experienced guide through the regulatory maze
Our clients approach us for support in a variety of situations, such as:
- Before regulatory authority inspections
- In connection with optimising existing production facilities
- While establishing new production plants
- To update their employees on the current GMP regulations
We respond with tailored consulting services including:
- GMP reviews
- Process validation
- Risk assessments
- Quality systems development
- GMP-related training courses
- Preparation for and accompaniment during audits
- Supplier audits
- Regulatory affairs
Getting you ready for GMP inspections
Our goal is to help you succeed with all regulatory authorities – including European, US-FDA, WHO and local GMP regulations. That is why we conduct “mock inspections” to discover problems and solve them before your official inspection.
We also work with you on new ways to adapt to regulatory trends – helping you attain more efficient production levels and higher quality products.