Core services
Regulatory Affairs
Regulatory Intelligence
- Regulatory environment and Outlook
Current regulatory life cycle requirements outline - Healthcare System Key developments and trends
- Pharmaceutical Business ecosystem and trends
Strategy and Consulting
- High level Regulatory & Supply Chain Strategy (Submission planning)
- Regulatory Project Plan (from ideation to product launch)
- Regulatory Risk mapping and mitigation plan.
Quality Assurance
- QMS
- Health accreditation
- Health registrations (product life cycle)
- CTD Gap assessment against local requirements and mitigations plans to bridge the gaps.
- Dossier country specific adaptation from core dossier.
- Dossier GAP Analysis
Labeling adaptation and lifecicle managment
- Artwork Creation
Market Access
- Product viability
- Distribution channels
- Public or private market
- Monitor regulatory and legal landscape and potential competitors.
Sanitary Surveillance
- Implementation of Surveillance
- System In Company
- Training
- Case Management
- Security reports
- Quality System applied to Surveillance
- Audits
- Building consensus on cross-functional, multi-agency teams.
- Strategies based on our Knowledge of public health, practices, and programmatic implementation.
Compliance
- Context and Initial Surveys
- Policy Development and Documentation
- Diagnosis and Work
- Staff Awareness and Training – Compliance Program
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