What can we do for you?
Our interim regulatory affairs (RA) support services provide the ideal solution to enhance your team or tackle an increased workload. Our experienced regulatory professionals can step in seamlessly to manage ongoing regulatory submissions and correspondence, ensure compliance with local and international regulations, and support product lifecycle management.
For project-based needs or specific regulatory milestones, our temporary RA support offers flexible solutions tailored to your timeline and objectives. Our services include the preparation and submission of regulatory documents, coordination with regulatory authorities, and review and update of regulatory strategies.
To ensure continuous compliance and strategic guidance, our long-lasting RA services offer sustained regulatory support to complement your team. We offer comprehensive regulatory strategy development and implementation, ongoing monitoring of regulatory changes and impact assessments, and long-term planning for product approvals and market expansions.
Partner with us for all your regulatory affairs needs and benefit from our commitment to excellence, strategic insights, expertise, and unwavering support. Contact us today to discuss how we can assist you with your regulatory challenges.
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
We offer a comprehensive range of regulatory affairs services designed to support your product's journey from development to market. Our services include regulatory strategy development, preparation and management of regulatory submissions, due diligence and gap assessments, and life-cycle management. We also provide specialized support for orphan drug designation, scientific advice applications, clinical trial applications, and writing of Module 3 documentation.
Regulatory affairs support can significantly expedite the product approval process by ensuring that all submissions meet the stringent requirements of regulatory authorities. Our team provides strategic guidance, thorough preparation of necessary documents, and effective communication with regulatory agencies. By streamlining processes, identifying potential issues early, and maintaining compliance, we minimize delays and increase the likelihood of a swift approval, helping you bring your product to market faster.
The duration of our regulatory affairs support services varies depending on the specific needs and scope of your project. It can range from a few days/weeks for specific tasks to several months or even years for ongoing support. We work closely with you to provide accurate timelines tailored to your project's unique needs.