What can we do for you?
We offer comprehensive support in designing your non-clinical development strategy and program to maximize the likelihood of moving your drug candidates into the clinic (CTA/IND) and onto the market (MAA/BLA/NDA).
Our team ensures that your non-clinical development strategy and program meet the scientific and regulatory requirements defined by the EU, US, UK and other regulatory authorities, paving the way for smooth approval processes.
Our support in study design includes:
- Pharmacology studies including safety pharmacology
- Pharmacokinetic studies including absorption, distribution, metabolism and excretion studies
- In vitro Drug interaction studies
- Toxicology studies including single and repeat dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, studies in juvenile animals, local tolerance, immunotoxicity studies as well as studies on qualification of impurities
Moreover, we assist in Protocol Assessment/Development of non-clinical/toxicology studies.
Contact us to discuss how our tailored approach can support your regulatory requirements and advance your research objectives. Together, let’s shape the future of safer and more effective therapies.
Watch how we maintain the highest professional standards
Approach & Expertise
Learn how we can support you in meeting your business goals
- Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
- Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
- At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.