The real challenge of non-clinical/technical authoring is integrating and harmonizing diverse non-clinical PK, PD and toxicology findings within evolving guidelines while maintaining scientific rigor, precision and clarity.
We can assist you with the following:
Contact us today 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.
Clear, Compliant Documentation for Global Submissions
Our expertise
We provide specialized non-clinical regulatory writing services to support the development and registration of pharmaceuticals, biologics, advanced therapy medicinal products (ATMPs), RNA therapeutics, nanomedicines, vaccines, medical devices and combination products. Our experienced medical and regulatory writers deliver high-quality non-clinical documentation that consistently meets global regulatory requirements, including ICH, FDA, EMA, and MHRA guidelines.
Partner with Starodub’s regulatory experts today to leverage our expert writing services, streamline your regulatory submissions and accelerate your path to clinical development and marketing authorization.
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.
