Putting YOU at the ‘core’ of SwissCore
Armed with a team of vastly experienced regulatory & sourcing professionals, adept in project management, we have an edge in delivering unmatched services to our clients.
Sourcing and Procurement Services
Our product sourcing team has access to manufacturers of quality pharmaceutical products, medical devices and consumables. These products are sourced for registration, tenders and named patient supply, along with the necessary documentation. We also help procure refence listed drugs (RLDs) in large volumes of a single batch or multiple batches.
Regulatory and Dossier Management Services
We offer:
- Dossier preparation (for regulated and semi-regulated markets)
- Regulatory compliance and guidance
- Dossier lifecycle management with requisite gap analysis
- Dossier compilation and filing to concerned regulatory authorities
- Communicating with various project stakeholders for compliance
- Responding to regulatory queries from various regulatory agencies
Technology Transfer
We provide end-to-end solutions in
- Performing gap analysis based on customer documents
- Evaluating gaps with receiver sites
- Optimizing processes prior to transfer, wherever applicable
- Preparing risk evaluation and mitigation documents
- Preparing transfer/ validation protocols
- Preparing technology transfer summaries
- Monitoring technology transfer operation of commercial production
- Undertaking regular integrity and quality audits
- Troubleshooting and failure investigation
- Providing reformulation support in a mutually agreeable development facility