Accurate and timely site registration is a fundamental regulatory requirement for pharmaceutical and life sciences companies operating in regulated markets. Our Site Registration services support organizations in obtaining, managing, and maintaining critical global identifiers such as DUNS, FEI, SPOR, and CESP, ensuring seamless interaction with US FDA, EMA, EDQM, CDSCO, and other regulatory authorities.
We provide end-to-end site registration and lifecycle management support, minimizing regulatory delays and ensuring inspection readiness.
Comprehensive Site Registration Support
Our services cover all major global site identification and registration systems required for regulatory submissions and inspections.
Scope of Site Registration Services
- DUNS Number Registration
- DUNS number application and verification
- Site-specific and legal-entity mapping
- Support for DMF, eCTD, and regulatory submissions
- Updates and maintenance of DUNS records
- US FDA FEI (Facility Establishment Identifier)
- FEI request and coordination with US FDA
- Support for drug manufacturing, API, and excipient sites
- FEI linkage with DMFs, ANDAs, NDAs, and site registrations
- FEI updates during site changes or inspections
- EMA SPOR Registration
- SPOR (Substance, Product, Organisation, Referentials) data submission
- Organisation Management Service (OMS) registration
- Location and manufacturing site data entry
- SPOR data maintenance for EU regulatory compliance
- CESP Registration
- CESP account setup and configuration
- Submission readiness for EMA and EU authorities
- Gateway testing and technical compliance support
- Lifecycle management of CESP submissions
Regulatory Authorities & Systems Covered
Our site registration services align with:
- US FDA (DUNS, FEI)
- EMA & EU Regulatory Network (SPOR, CESP)
- EDQM & CEP Submissions
- eCTD & Regulatory Gateway Requirements
- ICH & Global Regulatory Standards
This ensures smooth regulatory interactions across US, EU, and global markets.
Risk-Based & Accuracy-Focused Approach
We follow a data-accuracy and regulator-aligned approach to site registration, ensuring consistency across submissions, inspections, and regulatory databases. Our focus on correct site linkage prevents delays, rejections, and inspection findings related to incorrect facility information.
Key Deliverables
- Confirmed DUNS, FEI, SPOR, and CESP registrations
- Site data verification and regulatory alignment
- Submission-ready site identifiers
- Ongoing update and change management support
- Inspection-ready site registration records
Why Choose Our Site Registration Services?
- Global Regulatory Expertise
Experience with FDA, EMA, EDQM, and international systems. - Error-Free & Timely Registrations
Accurate data entry to avoid regulatory delays. - End-to-End Lifecycle Support
From initial registration to updates and maintenance. - Integrated Regulatory Services
Seamless coordination with DMF, eCTD, CEP, and audit support. - Confidential & Secure Data Handling
Protection of sensitive site and regulatory information.
Industries We Support
- Pharmaceutical Formulation Manufacturers
- API & Intermediate Manufacturers
- Excipient Manufacturers
- Contract Manufacturing Organizations (CMOs)
- Export-Oriented Pharmaceutical Companies
- New and Existing Manufacturing Facilities
Build a Strong Regulatory Identity
Accurate site registration is the foundation of global regulatory compliance. Our Site Registration (DUNS, FEI, SPOR, CESP) services ensure your facilities are correctly identified, compliant, and ready for inspections and submissions worldwide.
Register right. Submit smoothly. Comply globally.
