At CROlife, being a full-service partner means guiding you through every step of the clinical development journey. From protocol design and regulatory strategy to clinical operations, monitoring, data management, biostatistics, medical writing, and pharmacovigilance, our multidisciplinary team ensures seamless coordination, precision, and efficiency across all phases of your project.

We make certain that every study complies with the highest international standards, fully aligned with ICH-GCP, ISO, and global regulatory requirements. Our regulatory affairs experts work side by side with your team to secure timely approvals, maintain compliance, and uphold exceptional quality throughout the process.

Our specialists bring extensive experience across key therapeutic areas such as ophthalmology, oncology — including both solid and liquid tumors — respiratory diseases, gynecology, cardiology, and rare diseases. This deep therapeutic understanding allows us to anticipate risks, refine study designs, and deliver robust, reliable data.

Every trial we design revolves around the patient. By focusing on real needs and experiences, we improve recruitment, retention, and engagement. Whether through decentralized or hybrid models, or the use of advanced digital tools, we make clinical research more accessible, efficient, and patient-friendly.

Working with CROlife means benefiting from clear communication, transparent timelines, and flexible resource allocation. Our experienced project managers ensure that milestones are achieved on schedule, budgets are optimized, and potential risks are addressed proactively.

Thanks to our strong global presence combined with deep local insight, we can rely on a vast network of sites, investigators, laboratories, and regulatory experts. This enables rapid site activation, optimized study execution, and consistently successful project outcomes worldwide.

Our Regulatory Affairs services for pharmaceuticals and medical devices are designed to ensure that every stage of your product development meets global regulatory standards with efficiency, precision, and strategic vision.

We support clients throughout the entire regulatory lifecycle — from early development to marketing authorization and post-market compliance. Our regulatory experts combine scientific excellence with a thorough understanding of national and international frameworks, including EMA, FDA, MHRA, and other global authorities.

For pharmaceutical products, we provide comprehensive support covering regulatory strategy, scientific advice procedures, IND/CTA submissions, orphan drug designations, variations, and lifecycle management. For medical devices, we offer expert guidance on CE marking, EU MDR compliance, technical documentation, clinical evaluation reports (CERs), and registration processes across global markets, including the EU, the US, and emerging regions.

As your trusted regulatory partner, we help you navigate complex and evolving requirements, develop and implement tailored regulatory strategies, prepare and submit high-quality documentation, and communicate effectively with regulatory authorities on your behalf.

Our approach ensures that every project proceeds with clarity, compliance, and confidence — minimizing risk, accelerating approvals, and supporting long-term market success.