Quality Matters Safety Matters Pty Ltd acts as an accredited TGA agent for more than 50 different sponsors of medicines and medical devices in Australia.

We aim to ensure that

  • All sponsors are fully aware of their obligations
  • All sponsors have the resources on hand to realise their obligations
  • All products are fit for purpose and correctly included in the ARTG and
  • Any issues, concerns or problems are dealt with promptly and professionally.

COMPLEMENTARY MEDICINES

We offer a comprehensive ‘listing’ service as well as expert assistance in

  • New complementary medicines substances
  • Registered Complementary Medicines
  • Compliance matters and more.

Our Listing services includes

  • Full literature reviews, as well as copies of the full literature set
  • SOPs describing obligations of sponsors (Recall, customer complaints, stability testing, annual product review, adverse events reporting, etc)
  • Liaison with your manufacturer
  • Drafting of labels
  • Documented label checks
  • Submission of the approved draft.

Our clients have more than 200 different medicines included on the ARTG.

Contact us talktous@qualitymatterssafetymatters.com.au for obligation free advice and/or a quote.


PIC/s GOOD MANUFACTURING PRACTICE

We offer a range of services including

  • Due diligence auditing for contract manufacture
  • Mentoring in establishing GMP systems
  • Documentation, Training, Auditing and debilitated Validation expertise
  • Trouble shooting and more

We have more than 25 years experience in a wide range of dose forms, with a special focus on small and medium operations.

Our clients have and do include

  • API Manufacturers
  • Liquid dose form manufacturers
  • Solid dose form manufacturers
  • Due diligence for investigational medicines
  • Fermentation and bio-processors
  • Australian and International clients

Contact us talktous@qualitymatterssafetymatters.com.au for obligation free advice and/or a quote.


OTC’s and PRESCRIPTION MEDICINES

We don’t offer assistance with prescription medicines registrations but can connect you obligation free with people who can assist you.

Quality Matters Safety Matters Pty Ltd

Contact: 0439 782 869 talktous@qualitymatterssafetymatters.com.au

Quality management consultancy services tailored to your specific needs.