SERVICES

Regulatory Affairs:

- Regulatory strategy and guidance
- Global registration and dossier submissions
- Compliance assessments and audits
- Labeling and packaging compliance

Quality Assurance and Compliance:

- Good Manufacturing Practices (GMP) audits
- Quality system development and implementation
- Supplier qualification and management
- Validation and qualification service

Clinical Research and Development:

- Clinical trial design and management
- Site selection and study monitoring
- Data management and statistical analysis
- Pharmacovigilance and safety reporting

Market Access and Reimbursement:

- Pricing and market access strategy
- Health economics and outcomes research
- Reimbursement dossier development
- Payer and reimbursement negotiation support

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