Pharma Consulting
Clinical Development Services
- Strategic input for Clinical Development Programmes
- Development of Target Product Profiles and Clinical Development Plans
- Process review, SOP/WI preparation and review across the whole of the development process
- Outsourcing and managing development programmes to external vendors
- Medical, clinical and statistical support for publications
- Development support for regulatory submissions
- General development consultancy
Project Management Services
- Preparation and management of Project Development Plans
- Preparation and management of Project Development Budgets
- General Project management, from project definition through to completion
Clinical Data Management and Statistics
- Strategic input for Drug Development Programmes
- Process review, SOP/CWI preparation and review
- Selection and management of Statistical and Data Management CROs
- Statistical support for publications
- Statistical and Data Management support forregulatory submissions
- General Statistical and Data Managementconsultancy
Physician Services
- All aspects of Pharmaceutical Medicine including :
- Phase I – IV R & D
- Clinical pharmacology
- Medical marketing
- Regulatory
- Business development
- Investor relations
- Due diligence
CMC
- Manufacturing strategy
- Development planning
- Trouble shooting
- Supply chain management (early stage through to commercialisation)
- Technology transfer
- Manufacturing project management (including CMO liaison)
- Analytical support
Management
- Departmental interim management
- Process review and implementation
- Due diligence of in-licensing and out-licensingevaluations
- Management and technical input into regulatory inspections
Quality Assurance
- Development of Quality Management Systems
- SOP development
- Training on GCP requirements
- Management and technical support for regulatory inspections
