Pharmaceutical approval, clinical trials & medical writing
We offer a wide range of services for pharmaceutical approval, clinical trials and other activities in the medical sciences.
As an independent service provider, we offer you professional advice and support throughout the entire pharmaceutical approval process:
- planning, completion and coordination of all necessary steps involving national pharmaceutical approval applications
- Assistance with the pharmaceuticals licensing process and renewal applications
We help you conduct clinical trials and obtain the necessary approvals in Switzerland.
- Advice and help coordinating the preparation of clinical trial applications for chemical agents
- Planning, completing and monitoring clinical trials
- Help dealing with regulatory authorities (Swissmedic, ethics commission, etc.)
Our team prepares medical and scientific documentation.
For pharmaceutical approval
- CTD documents, such as expert opinions during the preclinical and clinical stages
- Approval documents
For clinical trials
- Final reports from trials
- Trial protocols
- Investigational Medicinal Product Dossier (IMPD)
Information for specialists and consumers
- Summary of Product Characteristics (SmPC)
- Patient Information Leaflet (PIL)