- Dedicated Tech transfer team with assigned responsible person from each department
- Highest confidentiality and IP protection standards
- Full analytical support in Transfers, Development & Validation
- Process scale-up from lab to pilot plant kg scale and multi-tons synthesis
- Preparation of comprehensive regulatory documentation in an eCTD format.
- Excellent product quality at competitive manufacturing costs
- Quality assurance system compliant with cGMP requirements
- World class regulatory support for product registration process in the most demanding of markets - US, Europe, Japan, Korea, Brazil and many others.