Our dedicated regulatory support services encompass compliance with international guidelines, correct documentation preparation and submission, and continuous communication with regulatory authorities on your behalf. We are committed to effectively managing these regulatory requirements to guide your products seamlessly from research and development to successful market approval and beyond.
What can we do for you?
The field of biological medicinal products is particularly diverse. Our team has been involved in the development and registration of amongst other several vaccines, ATMPs (advanced therapy medicinal products), antibodies and biosimilars.
We provide regulatory support for the development and marketing of your biological/biotech product at any step in the development and registration process; from guiding strategic development decisions, requesting scientific advice, applying for ATMP or biosimilar classification at the EMA or FDA, to assisting in authoring and/or reviewing of your registration dossiers.
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.