About Us
DMS Solutions was founded with a vision to provide 'ON THE GO' Regulatory Affairs and Pharmacovigilance services to Healthcare industries across the Globe. The concept 'ON THE GO' is envisioned to accommodate any project across the globe no matter how small or complex it may be.
Why Us?
We have a team of high calibre professionals who have significant experience and strong reputation in obtaining fast regulatory approvals and providing robust Pharmacovigilance system whilst adhering to specific regulatory guidance.
Our regulatory experts believe in delivering lean strategies which is them most cost efficient when it comes to the lifecycle management of the products.
You should definitely choose us if you are a start-up or simply looking for a support on a small ad-hoc project.
Services
Regulatory Affairs
Clinical Regulatory
Regulatory Affairs
- 'ON THE GO' CMC Projects
- Marketing authorisation application
- Pre & Post Approval CMC authoring
- Regulatory Due Diligence
- Drug product licence maintenance
- Gap analysis
- Global regulatory strategy and intelligence
- Dossier complilation, publishing and submissions
Pharmacovigilance
Clinical Regulatory
Regulatory Affairs
- Setting up EU compliant PV system
- Signal detection
- Risk management plan writing and implementation
- QPPV services
- Eudravigilance registration
- PV audits and inspection support
- PSURs and Urgent safety measures management
Clinical Regulatory
Clinical Regulatory
Clinical Regulatory
- Clinical trial applications and amendments
- Development CMC
- Global IMP labelling and translation services
- Support through all phases of clinical trials for any CMC related aspect
- All services will be delivered in line with current legislations and regulations.