Our services
Turio Ltd offers a full range of Pharmaceutical Consulting Services which include:
Project Management:
- Scientific, technical and strategic project management from early drug discovery up to clinical trials stage
- Bridging between the client’s internal teams and outsourcing organizations
Strategic Regulatory CMC Consulting:
- Advising on appropriate regulatory strategy
- Recommending the best route to the market
- Drawing up formal project plans with resource allocation and cashflow analysis
- Design of suitable studies and protocol preparation
- Monitoring to keep the project on track
Compilation and submissions of RA dossiers:
- Regulatory submissions preparations/review for US, EU and other National Agencies world-wide; Expert report authoring – pharmaceutical, pre-clinical
- Assistance in communicating with National Agencies and preparing for RA meetings with agency officials on application issues
- Due diligence review of regulatory dossiers
Compliance and Audits:
- Pre-Approval Inspection readiness
- Mock inspection (GMP, GLP) conducted by former FDA or MHRA inspectors; we are able to conduct audits world-wide
- Due diligence audits and assessments
- Preparation of responses to FDA 483 citations or EU inspections reports
Training:
- Conducting on-site custom seminars on Regulatory Affairs Issues and Compliance Issues
- Delivery of formal seminars and training conferences