Bio-Pharmaceutical & Medical Device Industry Consultancy

Providing high-quality support to our customers through a full range of services tailored to the Bio-Pharmaceutical and Medical Device industries

Sectors We Specialise In

How We Can Help You

Quality Assurance

  • Quality systems design, strategy and implementation through the product’s life cycle.
  • Quality systems audit support
  • Quality systems Health Authority
  • Inspection readiness
  • Quality Operation Management

Regulatory Compliance

  • Product life cycle compliance management
  • Medical device regulation support
  • Pre-approval – BLA/IND/NDA
  • Post-approval – Variations

Clinical Services

  • Clinical Trial process support
  • CTM Management
  • GCP Audits
  • CTR Experts

Specialised QP and RP Services

  • Support clients with MIA/WDA licenses
  • Host GDP and GMP inspections
  • Ensure compliant manufacturing and distribution of products
  • Support multiple types of formulations and complex supply chains