Our systematic evaluation ensures that all necessary regulatory information is complete, accurate, and aligned with the latest standards and guidelines. By thoroughly assessing your files, we help you proactively address any deficiencies or omissions, thereby enhancing the quality of your submission and increasing the likelihood of obtaining marketing approval. This not only streamlines the approval process but also minimizes the risk of delays or rejections due to regulatory non-compliance.
What can we do for you?
Our team of experts brings extensive experience in evaluating a variety of regulatory documentation, for all aspects of drug development (non-clinical, clinical and CMC) and during all phases of development (clinical phases, MAA/BLA and post-approval).
We provide you with an extensive gap and risk assessment report including a SWOT analysis (strengths, weaknesses, opportunities, and threats).
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.