THE QUANTIC GROUP SERVICES
Strategies
- Pharmaceutical
- Biotechnology
- Gene Therapy
- Vaccines
- Blood Fractionation
- Over-the-Counter
- API
- Vitamins
- Devices
- Nutraceutical
Organization
- Organization design & effectiveness
- Quality organization design
Products
- Product development technology strategies
- Formulation & methods development
- Regulatory submissions
- Prepare complete BLA submissions
- Support PAI readiness
- Product & method optimization
- Product quality performance assessment
- Process analytical technology support
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Facilities
- Capital project conceptualization & implementation
- Design of facilities & equipment
- Design pilot plants
- Layout of production, formulation and secondary/packaging
Clinical & Safety
- Clinical study design & data analysis
- Pharmacovigilance processes
Quality & Compliance
- Presentations to FDA, other regulators
- Prepared global policies, standards and guidance
- Quality system design
- Pharmacovigilance systems & programs
- Clinical study evaluations
- Regulatory audits & risk assessment
- Audit multiple facilities and participated in corrective action
- Remediation planning & implementation
Efficiency
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