TECHNICAL SOLUTIONS
CTD / ACTD Support
Structured review of regulatory dossiers.
Compilation and technical review of CTD / ACTD documentation.
Discuss your project ↗
From brief to delivery
1
Research
Define the product and technical requirements.
2
Pre-formulation
Compatibility screening and physicochemical characterization.
3
Development
Formulation and process development.
4
Analytical validation
Analytical method development and validation.
5
Scale-up
Support progression from laboratory to pilot scale.
6
Process validation
Validation protocols and process optimization.
7
Technology transfer
Transfer dossiers, master batch records and stability data.
8
Commercial support
Manufacturing coordination and regulatory filing support.
YOUR NEXT STEP
Submit product requirement ↗Looking for a specific API, formulation or technical solution?
Share your product, quantity and documentation requirements. Let’s take the next step together.