THE QUANTIC GROUP SERVICES

Strategies

  • Pharmaceutical
  • Biotechnology
  • 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

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

  • Operational excellence