Our role at Skillpad is to help you with your Compliance, Quality Assurance and Project Management needs in the regulated realm such as in Pharmaceuticals, Biotech, Cosmetics and Natural Health Products. We offer services à la carte or any combination of services right up to Turn-Key processes. We have Consultants with specific and broad expertise who can assist you in Quality Programs, Auditing, Standard Operating Procedures, Inspection Readiness, Vendor Oversight Processes, Project Management, Regulatory Affairs and Validation Services.

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Quality Programs

  • Set-up of new programs, management and support
  • Enhancement of existing systems
  • Quality Control and Quality Assurance services (interim or on-going)
  • Preparation or right-fitting of Quality Manual
  • Change Control and/or CAPA strategies and tools
  • Deviation investigation system

Auditing

  • Development, management and/or evaluation of audit programs
  • Audit planning and execution of audits including liaison with auditee
  • Support post-audit

 Standard Operating Procedures (SOPs)

  • Preparation of SOPs or SOP program
  • Review of existing SOPs, re-design and/or streamlining
  • All processes from development of SOPs to training

 Inspection Readiness

  • Mock-Inspection execution
  • On-site/webinar coaching
  • Post-inspection support

 Vendor Oversight Processes

  • Strategies and SOPs
  • Development of metrics
  • Qualification and Auditing
  • On-going evaluation

 Project Management

  • Risk Identification
  • Scheduling
  • Project planning, tracking and evaluating

 Regulatory Affairs (cosmetics)

  • Liaison with European Cosmetics agents
  • Support with preparation of cosmetics regulatory dossiers
  • Labeling review

 Validation Services (Equipment & Utilities Systems, CSV, Software, Cleaning)

  • Preparation of Validation Master Plan (VMP)
  • Development/execution – Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocols
  • Preparation of Validation Reports

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