What can we do for you?
Our team begins by punctiliously identifying the sources that are most applicable for regulatory screening, including industry guidelines, regulatory authority publications, and other critical regulatory resources. We then regularly check these identified sources to capture any relevant updates or new regulations, ensuring that no important regulatory change is missed.
All changes are documented and stored in a comprehensive database, allowing for easy tracking and reference of regulatory updates. This ensures that your compliance records are always up-to-date. We create concise summaries of new and updated regulatory guidance, highlighting key changes and providing a clear understanding of how they may impact your products and operations.
Our experts can also support you by conducting thorough impact analyses to determine the implications of regulatory changes on your products and company. This analysis helps you understand the potential actions required to stay compliant. We also provide full support for implementing regulatory changes into your processes, quality systems, and strategies. This includes offering strategic advice, helping you revise documentation, and ensuring that all necessary adjustments are made efficiently and effectively.
By partnering with us for regulatory guidance check services, you ensure that your products remain compliant and optimized for regulatory success. Our expert team is dedicated to helping you navigate the complexities of regulatory requirements with confidence.
Contact us today to learn more about how our services can support your regulatory needs and enhance your compliance strategy.
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
Regulatory guidance checks are essential for ensuring that your existing marketing authorizations and Active Substance Master Files (ASMFs) remain compliant with current regulatory standards. Our experts conduct thorough reviews to identify any changes in regulatory guidelines that impact your authorizations and ASMFs. We provide detailed recommendations on necessary updates, ensuring your documentation aligns with the latest requirements. This proactive approach helps prevent compliance issues, ensuring continuous market access and avoiding potential regulatory actions.
Regulatory changes can significantly impact your manufacturing processes and analytical methods. Our regulatory guidance checks evaluate how updates in regulatory guidelines affect these areas. We provide actionable recommendations to optimize your manufacturing processes, ensuring they comply with the latest standards. Additionally, we assess the need for implementing additional analytical testing to maintain product quality and regulatory compliance. By staying ahead of regulatory changes, you can enhance the efficiency and reliability of your manufacturing and testing procedures, ultimately ensuring the safety and efficacy of your products.