1. Consulting and advisory services

1. Drug safety - Pharmacovigilance resource options:

a. Non-central safety department Pharmacovigilance services incl:

• Outsourced named safety contacts, outsourced designated safety focal points or contacts required by regulations
• Healthcare professional (HCP) or consumer reporting management
• Case entry
• Regulatory reporting

b. Literature reviews

2. Commercial practices - Copy approval of external and internal documents & communications

1. Regulatory affairs resource options:

• Marketing authorisation holder support
• Horizon scanning in terms of regulatory landscape changes and impact on business requirements
• Application and dossier preparation and submission in CTD format
• Scheduling changes
• Evolving external environment requirements – e.g. Meeting the safety and efficacy (SE) requirements for registration of Health Supplements in SA

1. Medical information resource provision and customer centric query resolution

2. Patient support programme delivery

1. Commercial and Medical Excellence

• Training of sales force and medical affairs teams
• Business planning and execution
• Metrics

2. Medical writing services – e.g. FAQ development

Exsanté – PV (Product review, Pharmacovigilance and Product Quality Manager)

• Easy consumer and HCP access point – helps triage queries to where they need to go
• Product Feedback, Adverse Event & Product Quality capturing in accordance with company SOPs and regulations
• Management overview

Exsanté – RIM (Regulatory Information Manager)

• Compile electronic CTDs, or country specific CTDs
• Manage licenses, labels and track variations
• Audit trail

Exsanté – OS (Product and Disease Registries)

• From simple databases to full blown product or disease registries
• Graphical user interface component for data entry
• Validation component to check user data
• Reporting tool for analysis of the collected data

Exsanté – HPL (HR, Performance & Learning Management System)

• Employee record keeping, performance tracking and management
• Learning portal compatible with video, audio and text formats
• Expansion modules:
  • CRM; Business Optimizer; Workflow Manager

(Strategic Partnership)

• Business model dependant on the customer requirement
• Setting up operations in target markets
• Developing strategy
• Implementation and deployment of resources

          –Product registrations (Acting MA holder)

          –Supply planning

          –Importation, warehousing and distribution to all target markets

          –Launches

          –Scientific engagement

          –Deployment of sales force

          –Commercial oversight and reporting

          –Pharmacovigilance & Medical Governance