Preparation of the clinical trial applications requires working knowledge of local laws and regulations.
With successful track record of preparing documentation packages for the ministry of health and ethics committee review, Probiotech will deliver on timely approval of your next clinical trial.
Would you like to get expert guidance in the clinical trial application process?
Probiotech offers regulatory services that enable clinical trials compliance with local laws and regulations. We have the knowledge and expertise in preparing clinical trial submissions and gaining approval of the ministry of health and ethics committees. We work effectively in obtaining required import and export licenses for bringing the investigational product into the country and shipping patient samples for analysis. By maintaining regular communication with local regulatory authorities during application process we set realistic expectations and create common goals that lead to timely approval.
Our regulatory affairs services include:
- Preparation and filing of the clinical trial applications
- Gaining clinical trial approval from the ministry of health
- Obtaining clinical trial approval from federal and local ethics committees
- Acquiring import license for investigational product
- Obtaining export license for patient samples
- Pharmaceutical registration
Our vision for better medicine helps us communicate the value of the clinical research to local healthcare authorities.
We believe that our passion for better medicine enables us to drives prompt regulatory approvals.