This process is critical in scenarios such as mergers and acquisitions or in analyzing and mitigating risks from an investment decision. The objective is to uncover any regulatory risks which could impact product development, commercialization or the operational continuity of the business.
What can we do for you?
Our specialized team of quality/CMC, non-clinical, clinical as well as regulatory experts possesses extensive experience in conducting due diligence assessments. With a deep understanding of scientific and regulatory frameworks and thorough attention to detail, we are proficient at identifying potential gaps, deficiencies and risks. We identify the risks, so you are better prepared when bringing your innovation to the market and beyond.
We perform a high-level or in-depth due diligence assessment customized to your needs and scope. We present recommendations for improvement in your development programs to support the advancement of your drug candidate. We ensure that your program is well-prepared for successful regulatory submissions, clinical trials and in-/out-licensing purposes.
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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
Why is due diligence important for in- and out-licensing?
Due diligence is crucial to identify any gaps, deficiencies or risks in regulatory compliance during merging or acquisition. By conducting thorough assessments, companies can mitigate compliance risks, ensure product quality, efficacy and safety, and avoid regulatory issues that could delay product development or approvals or lead to costly remediation efforts.
What does a typical due diligence assessment process entail?
The due diligence process involves comprehensive evaluations of product quality, manufacturing processes, non-clinical pharmacology, pharmacokinetics and toxicology clinical trial data and regulatory compliance. This thorough review ensures that the drug candidate is safe, effective, and manufacturable to the highest standards, minimizing risks and maximizing the potential for successful development and commercialization.
How do you evaluate the regulatory aspects of a pharmaceutical product for potential in/out-licensing?
We use a SWOT (strengths, weaknesses, opportunities, and threats) analysis. A SWOT analysis is instrumental in assessing the regulatory considerations of a pharmaceutical product being considered for in/out licensing. It helps in identifying the product’s strengths in meeting regulatory requirements, such as robust manufacturing processes and quality control measures. Simultaneously, it highlights potential weaknesses, such as gaps in documentation or manufacturing scalability issues. Additionally, the analysis can uncover regulatory opportunities, such as expedited pathways or niche markets, and potential threats like regulatory hurdles or stringent compliance standards.