At Starodub, we offer comprehensive support for the development and regulatory approval of ATMPs, ensuring your products reach patients safely and efficiently.
What can we do for you?
Our ATMP Services Include:
- Regulatory Strategy Development: Tailored strategies, from early development to commercial phase, to meet specific regulatory requirements for ATMPs, such as gene therapies, cell therapies, and tissue-engineered products.
- Comprehensive Regulatory Support: End-to-end support throughout the development and marketing of your ATMP, including scientific advice, protocol assistance, ATMP classification at the relevant Health Authorities, and authoring or reviewing ATMP registration dossiers.
- Non-Clinical Support: Assistance with the preparation/assessment of non-clinical development strategies and plan, designing non-clinical studies covering pharmacology, pharmacokinetics and toxicology, selecting and managing CROs, authoring non-clinical parts of the regulatory documents, to ensure robust preclinical data and successful regulatory submissions.
- Clinical Trial Support: Comprehensive assistance in designing and conducting clinical trials for ATMPs, including protocol development and regulatory submissions.
- Quality and Manufacturing Compliance: Leveraging our CMC expertise, we provide strategic guidance on quality and compliance throughout the ATMP development process. With a strong understanding of industry standards, we offer high-level insights into GMP requirements critical for regulatory success.
- Regulatory Submissions: Expert preparation and submission of regulatory documents (IND/CTA to BLA/MAA), ensuring compliance with EMA and FDA guidelines.
- Post-Approval Support: Continuous regulatory guidance for post-approval activities, including life cycle management and compliance with evolving standards.
By leveraging our knowledge of the latest guidance and acquired expertise, we maintain a comprehensive view to identify risks and opportunities.
Partner with Starodub to navigate ATMP regulation confidently. Our expert team is dedicated to bringing innovative therapies to market, improving patient outcomes, and advancing medical science.
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.
