The complexity of regulatory operations is often a bottleneck in the development of pharmaceutical and biotech medicines. Coordinating multiple teams, managing extensive documentation, and ensuring compliance across regions requires significant effort — and even minor inefficiencies can extend submission timelines.
At Starodub, we specialize in helping companies transform Regulatory Operations from a compliance obligation into a strategic advantage. Our approach covers the full lifecycle of regulatory activities, ensuring submissions are timely, compliant, and in accordance with regional requirements.
Our Regulatory Operations Expertise Includes:
- eCTD Publishing – We manage multi-region submissions efficiently and in full compliance with current regulations for the regions EU, US, Canada, Switzerland, Australia, New Zealand and South Africa.
- Document Management System (DMS, including QMS) – Streamlining workflow processes and document maintenance, helping comply with regulations, reducing risk of data loss, improving ability to search for information, increasing collaboration, and providing enhanced version control.
- Regulatory Information Management System (RIMS) – We can support you in navigating the complexity and variability of regulations across regions. The ability to organize, structure, provide overview and analyse is part of our DNA.
- Submission Preparation Support – Our expert team with decades of industry knowledge, ensures your application is submission-ready.
- Electronic Submission Support – We offer end-to-end management of the submission process on your behalf.
- RO Support and Helpdesk – Any additional questions or support your company might need.
Why it Matters
Employing effective Regulatory Operations does more than reduce administrative burden — it accelerates time-to-market, improves cross-functional alignment, and facilitates more efficient review by the regulatory authorities. For organizations managing multiple regions and submissions, structured processes and expert guidance can prevent delays and inefficiencies ensuring high-quality dossiers reach regulators smoothly.
Whether your organization is looking to accelerate submissions, improve dossier quality, or optimize regulatory workflows, we bring practical, hands-on expertise.
Connect with us to explore how we can support you and help deliver products to patients faster.
