Scope
- Pharmaceuticals/Biologicals
- OTC
- Medical Devices
- Diagnostics
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Asia: Full Regulatory Service
- Direct operations in Asia
- Regional Hub Office
- Singpore HSA registered RA licence holder/agent
- Electronic submission access
- In-country Representatives
- Full Service
- Clinical Trial Applications
- Marketing Applications
- License Maintenance
- License Ownership at country level
EU: Full Regulatory Service
- Consultancy, strategic development
- National and EMEA Scientific Advice
- Clinical Trials Applications and maintenance
- Marketing Applications
- License Maintenance
- Local Agent legal status (UK)
- Country base staff (UK) and alliances
US: Consultancy Moving to Full Service
- Consultancy advice to financial/legal companies
- Regulatory strategy/issues consultancy
- Use of ex-FDA Divisional Director level people
- Full service demand from small companies
- Tactics for resourcing to provide full service
- IS/IT experience and capability (eCTD and document management) already in place through Alliance
License Maintenance
The Pharmaceutical Environment
- Need to reduce costs
- Forced cost reduction mandates from leadership
- Productivity gains of 10 to 20% expected
- Core competencies being re-defined
- Partnering and Outsourcing becoming preferred model
- Other specialist companies have emerged to deliver some activities to high quality but with flexibility on costs and resources
Pharma Company Regulatory Affairs Situation
- Finding sufficient experienced and highly competent RA people for new projects and company growth is difficult and costly
- Increasing demands on post-approval safety and CMC
- GMP/variations
- Manufacturing strategy changes
- Lower cost sourcing
- China market growth initiative from Corporate demanding Regulatory Affairs resources
- Internal productivity initiatives demanding management attention but external ‘regulatory creep’ continuing
Pharma RA Solution
- Re-examine Regulatory Affairs “core” competencies
- Qualitative/quantitative in corporate and country based RA
- RA budgets directed to fill core competency need
- Explore external partnering models for non-core competencies with more work output for same or lower budget
- Find right external partners with right regulatory affairs expertise, global experience, and delivery record conscious of impact of one regions impact on another; look at the risk and durability of outsourcing decisions
- Regulatory Affairs resource cuts in countries by non-RA people needs different solutions than pushing for internal resources
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| Example Of FDA Activities |
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RegAff License Maintenance - CMC Variations
Management Challenge
- Pharma needs ongoing CoG reduction
- Pharma needs cost effective solution for approval to sell product with manufacturing/pharmaceutical changes
RegAff Approach
- Provide high quality, efficient CTD format variations
- On-shore Regulatory Affairs expertise, QA and Client Liaison
- Off-shore service delivery of routine support to on-shore resources to enable cost reductions
Engagement covers:
- Obtaining Variation Application Approvals to implement changes within a defined time period
- Extend to long-term relationship and support authoring of complex variations across the portfolio
RegAff License Maintenance - Safety Variations
Management Challenge
- Pharma updates global labels after yearly analysis of reported safety data
- Pharma needs a cost effective solution to write Type II variations and implement revised labeling for marketed products
RegAff Approach
- Provide high quality, efficient CTD format variations
- On-shore Regulatory Affairs expertise, QA and Client Liaison
- off-shore service delivery of routine support to on-shore resources to enable cost reductions
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Information Management
Cost efficient management of documents and electronic submissions to health authorities using globally accessible, secure repositories (US based servers and storage) at Clinical Trials Application, Marketing Application and Product License maintenance phases.
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| Regulatory Operations |
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