Medicines

Accredited TGA Agent for Medicines in Australia

Quality Matters Safety Matters Pty Ltd acts as an accredited TGA agent for more than 100 different sponsors of medicines and medical devices in Australia.

We strive 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 
  • 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 include:

  • 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 300 different medicines included on the ARTG.

  • Slide title

    Write your caption here
    Button

  • Slide title

    Write your caption here
    Button

  • Slide title

    Write your caption here
    Button

  • Slide title

    Write your caption here
    Button
  • medicines

    Slide title

    Write your caption here
    Button
  • herbal medicines

    Slide title

    Write your caption here
    Button
  • different coloured medicines

    Slide title

    Write your caption here
    Button
  • medicine packets

    Slide title

    Write your caption here
    Button

PIC/S Good Manufacturing Practice

Quality Matters Safety Matters Pty Ltd offers a range of services including:

  • Due diligence auditing for contract manufacture
  • Mentoring in establishing GMP systems
  • Documentation, training, auditing and debilitated validation expertise
  • Due diligence for investigational medicines
  • Trouble shooting and more

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

Our clients include:

  • API manufacturers
  • Liquid dose form manufacturers
  • Solid dose form manufacturers
  • Fermentation and bio-processors
  • Australian and International businesses

OTC and Prescription Medicines

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

Contact: 0439 782 869

 talktous@qualitymatterssafetymatters.com.au

Online Contact Form
Share by:

Powered by Telstra Business Website Services