Services

We provide a wide range of Services

Consulting

  • Clinical Supplies Project Management
  • Quality Assurance and Compliance
  • Auditing
  • Staff Training
  • Controlled Drug Substances training
  • Medical Devices and Combination Drug/Device Products
  • Regulatory Compliance
  • SOPs
  • Quality Manuals
  • Drug Development dossiers
  • Due Diligence Services for Venture Capital Firms
  • Staffing
  • Herbal, Food and Dietary Supplements
  • Drug Sourcing analysis

Audits

We conduct audit for the TGA and FDA in GMP, GCP, GLP, GTP, and QSR.

Our auditors travel to Australia, New-Zealand, China and India

  • Audit to qualify CMOs
  • Assist in setting up CAPA programs
  • Assist in internal and external audits
  • Audit packaging and labelling contractors
  • Audit of analytical labs
  • Pre-Approval inspection audits
  • Audit clinical facilities for TGA and APVMA compliance
  • Conduct Due Diligence audits

Training

We have a team of trainers who can assist you in house with

  • GMP and GDP training
  • Aseptic compounding
  • QA Processes
  • Internal audits protocols

We also tailor make any training for your specific needs

EHS

Today, occupational safety and health regulations are broad and far-reaching. They require employers in the Bio Pharma industry to keep their places of employment safe and free of recognised hazards likely to cause death or serious harm to employees and to maintain workplace health and safety.

We develop and implement a Bio Pharma specific EHS manual, and procedures tailored to your business to help with Safety and Compliance.

Suppliers

We conduct suppliers’ qualifications, reviews and audits anywhere in Asia Pacific to give you the peace of mind and maintain compliance.

Would you like to start a work with us?

Reach out to us if you have any questions

+61468 350 940