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
Protocol Development:
- Scientific protocol design & optimisation
- Feasibility analysis & site landscape
- Endpoint strategy & statistical considerations
- Protocol amendment management
Medical Writing:
- Clinical study reports (CSRs) & investigator brochures
- Regulatory submission documents & IND/NDA narratives
- Patient narratives & safety reports
- ICH E3 compliant deliverables
Pharmacovigilance:
- Safety data management & adverse event reporting
- Signal detection & evaluation
- PBRER/PSUR authoring & risk management plans
- MedDRA coding & regulatory safety submissions
SAS Programming:
- SDTM/ADaM dataset programming
- Tables, listings & figures (TLFs)
- Define.xml generation & CDISC compliance
- Pinnacle 21 validation & submission readiness
Clinical Technology
Integrated eClinical platform with EDC, RTSM, RBQM, ePRO, and more.
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