 |
 |
We provide services at all stages of the drug development process. All
projects from one-offs to complete development packages are undertaken
in accordance with GCP regulations. The following is an outline of the
services we provide. |
- Preparation of documents for investigational products
- Preparation of clinical protocols
- Preparation of explanatory documents for agreement acquisition
- Selection of clinical trial sites
- Selection of clinical trial personnel: controller, coordinator, medical
expert, etc.
- Contract support for medical institutions
- Monitoring support
- Delivery and collection of investigational products
- Collection of case reports
- Preparation of final reports
- Preparation of theses for publication (clinical and non-clinical)
- Manufacturing of pharmaceuticals and medical devises and preparation of
import permit applications
- Consultation with regulatory bodies and support and follow-up of regulatory
submissions
- Quality control
- Quality assurance
|
|