Characterized by conscientious chemical processes and stringent development protocols, the domain of small molecule drug products necessitates rigorous adherence to ensure the efficacy and safety of your products. Effectively navigating the regulatory landscape requires a comprehensive grasp of international guidelines, meticulous preparation of documentation, and continuous dialogue with regulatory agencies. Successfully managing these requirements is essential for advancing your product from research and development through to market approval and beyond.
What can we do for you?
We provide regulatory support for the development and marketing of your original small molecule or generic drug product at any step in the registration process; from guiding strategic development decisions and requesting scientific advice to assisting in authoring and/or reviewing your registration dossiers and maintaining them via variations.
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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.
Questions from our clients
FAQ Section
What regulatory support is essential for the development and approval of small molecule (or generic) drug products?
Regulatory support for small molecule (or generic) drug products focuses on comprehensive CMC (Chemistry, Manufacturing, and Controls) activities. This includes developing a strategic regulatory pathway, conducting gap analyses, and ensuring compliance with regulatory guidelines for, amongst other, manufacturing processes. Key activities involve preparing detailed CMC documentation, provide regulatory support for validation studies for analytical methods or design of stability studies, and (facilitating) interactions with regulatory agencies to ensure a smooth approval process.
What specific regulatory considerations are involved in the development and approval of generic drugs?
For generic drug products, it is essential to demonstrate that they are essentially similar to the reference medicinal product (RMP). This is typically achieved through bioequivalence and in-vitro studies (amongst other dissolution studies) and these results must be submitted to regulatory authorities for approval. For some generics, such as parenteral drugs, these studies may not be required, and for other products a biowaiver can be requested. Essential considerations include preparing detailed CMC documentation for submissions, exclusivity issues, and managing post-approval changes and post-marketing surveillance to ensure ongoing compliance and market success.