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Services

Quality Management Systems (QMS)

  • Handling of Regulatory Audits:
    1. Conduction of gap analysis audits and advice on remedial actions
    2. Project management of audit preparations in line with quality requirements (experienced in handling audits by, among others, the US FDA)
    3. Assistance with formulating responses for audit findings
    4. Auditing of 3rd party manufacturers, suppliers of raw materials and components on behalf of clients
  • Conduction of root cause analysis investigations, quality risk assessments and plans for corrective actions and preventative actions (CAPA)
  • Training of personnel on QMS and Good Manufacturing Practice (GMP)
  • Execution of Validation Studies: Process Validation and Analytical Test Methods
  • Compilation of pertinent regulatory documentation such as Standard Operating Procedures (SOPs), Site Master Files (SMF), Quality Manuals, Validation Master Plans (VMP)

Health Economics

  • Conduction of Pharmacoeconomic Evaluations
  • Conduction of Budget Impact Analysis
  • Assistance with the formulation of Market Assess Strategies
  • Assistance with Reimbursement Decisions
  • Conduction of Willingness-to-pay Research Studies
  • Tracking of Price Evolution and Trajectory

Regulatory Affairs

  • License applications:
    1. Manufacturing Authorization to manufacture, import and export medicines
    2. Marketing Authorization for New Chemical Entities (NCEs)
    3. Marketing Authorization for Generic Drugs
  • Updating of Dossiers in line with Post Registration Amendments
  • Advice on Regulatory Compliance