Smooth Drug Development provides services for pre-clinical studies at leading laboratories.
Studies in animals – an important stage in the development of innovative and generic drugs in terms of getting the data for further study in humans and marketing approval. Quality of the experiment plan determines not only time and costs of development, but also defines reliable results that will influence the future place of the product on market.
In accordance with the requirements of ISO 9001:2008, our company is very attentive to the choice of laboratories. Before they get to the list of approved suppliers, laboratories pass a selection process that includes an assessment of the documentation and quality audit. In the future, we conduct regular audit of the laboratory, as well as for-cause audits.
Our company has extensive experience in pre-clinical studies of novel and generic pharmaceutical and biotech products.
In collaboration with our partners we provide the following services:
- Analysis of documents for performed research
- Development of a plan for additional research
- Selection of a laboratory from the list of approved vendors
- Selection and quality audit for new laboratories if needed
- Management of laboratory during the project
- Development of research program and plans
- Conduct of experiments
- Preparation of research reports
- Quality control of documentation
The most common types of studies:
- Acute toxicity assessment
- Assessment of sub-chronic toxicity and local irritant action
- The pharmacokinetics and pharmacodynamics
- Research of cumulative effects
- Research of specific pharmacological activity
- Evaluation of specific toxicity:
- allergenic effect
- reproductive toxicity
Our partners offer a wide range of research on models of various conditions and diseases. If necessary, we provide research on primates.
Smooth Drug Development – full-service CRO, provides services for pre-clinical studies since 2011.