Critical and Advanced Intermediates
- We can assist you in selecting starting materials considering the current regulatory requirements while optimizing costs.
- We can plan with you a regulatory strategy to support your chosen starting material.
- Documentation for “critical” starting materials can be prepared in case these become GMP Intermediates.
By introducing a “backwards integration” solution package, we can help you in meeting stricter requirements for starting materials. Our services include:
- Supplier evaluation and qualification
- Compilation of regulatory documentation
- Regulatory support during registration and variation procedures.
We offer cost-effective solutions via N-1 intermediates produced under GMP for APIs under price pressure. Our services include those listed above under GMP Intermediates.
Midas enables access to chiral intermediates via either chemical or enzymatic catalysis.
Our proven track record rests upon broad experience and a range of narcotic intermediates for pharmaceutical applications. We comply with all regulations for narcotic and psychotropic substances, as well as precursors (scheduled substances "GüG"). We manage cross-border handling of controlled substances to meet your requirements.