Our Project Management and
Regulatory Consulting Services
Turio Ltd offers a full range of Project Management and Regulatory Consulting Services which include:
Strategic Regulatory Consulting Services:
- Advising on appropriate regulatory strategy
- Recommending the best route to the market
- Preparation of briefing package for pre-submission meetings with EMEA and FDA
- Regulatory strategy for product roll-out in international markets
Compilation and submissions of RA dossiers (Common Technical Dossier, CTD):
- Regulatory submissions preparations / review for the European Union – EU, FDA and other National Agencies world-wide
- Quality Overall Summary (QOS), Non-clinical Overview authorship
- Assistance in communicating with National Agencies and preparing for RA meetings with agency officials on application issues
- Due diligence review of regulatory dossiers
Project Management for Pharmaceutical and Biotech Companies:
- Scientific, technical and strategic project management from early drug discovery and drug development up to marketing
- Bridging between internal teams and outsourcing organizations
- Drawing up formal project plans with resource allocation and cash flow analysis
Other Pharmaceutical Consulting Services
Due diligence
- Due diligence audits and assessments for M&A, licensing activities and company / pipeline evaluation
- Portfolio evaluation of target companies
- Product development assessment and advice
- Regulatory Affairs evaluation – dossier assessment and gap analysis
Audits and Compliance:
- Compliance audits to assist M&A or in-licensing / supply activities (cGMP) conducted world-wide by former FDA and MHRA inspectors
- Pre-Approval Inspection readiness (EMEA and FDA cGMP guidelines)
- 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