Smooth Drug Development collaborates with several leading analytical laboratories in Russia and Europe.
Our company provides services in bioanalytical laboratory selection and management to meet the needs of any complex clinical trial.
The right selection of a laboratory is a key to success in bioequivalence trials and in obtaining bioavalability, PK and PD data.
In accordance with ISO 9001 requirements, our company is very serious about laboratory selection. Before vendor is included into our vendor list, we perform quality assessment of documentation and a vendor audit. After that, we perform regular and for-cause audits.
Together with our vendors we provide the following services:
- Laboratory selection from our vendor list
- Selection and audit of laboratories which are not included into our vendor list
- Laboratory management within clinical trials
- Development and validation of bioanalytical method
- Samples analysis
- Analytical report preparation
- Quality control of documentation
Our partners can develop bioanalytical methods in different biological matrices and perform validation in accordance with the relevant rules and international guidelines.
The laboratories have modern bioanalytical equipment and can provide accuracy and speed of work.