At Prime Services, we simplify the complexity of clinical trial regulations. Our regulatory experts ensure your study is aligned with evolving global standards—enabling faster approvals, smoother submissions, and complete compliance from start to finish.
We develop customized regulatory strategies tailored to your product, indication, and target markets. From early-phase planning to submission readiness, we provide proactive consultation to help you align with evolving global and regional guidelines.
Our team crafts and submits high-quality regulatory documents, including IND/CTA/CTN applications, clinical trial protocols and ICFs, IRB/EC submissions, and clinical trial registrations (CTR). Every submission is formatted, reviewed, and validated to meet the specific requirements of FDA, EMA, CDSCO, NMPA, and other global authorities.
We act as your regulatory liaison, managing communication with health authorities at every step—pre-IND meetings, scientific advice sessions, and post-approval follow-ups. We ensure that all queries, feedback, amendments, and variations are addressed with precision and speed.
| Multinational Submission Experience | FDA Submissions |
| Regulatory Intelligence Across Markets | EMA Applications |
| Health Authority Collaboration | CDSCO Filings |
| Risk Mitigation & Compliance | NMPA Coordination |
| Protocol Development | Safety Reporting |
| IRB/EC Management | Regulatory Strategy |
We streamline regulatory pathways and safeguard the integrity of your clinical development journey.
