If you’re looking to supply your products to the Australian market but are unsure on the surrounding regulations, PharmOut’s TGA regulatory affairs consultants, and our extensively-experienced architects, engineers, validation experts, GMP trainers and TGA GMP audit response consultants can support you every step of the way.
TGA Regulatory Affairs Consultants including TGA GMP Audit Response support
PharmOut’s expert consultants are familiar with the TGA’s framework for managing and classifying the vast range of products that come under the definition of therapeutic goods by the TGA (as pictured below). Our services can assist organisations at start-up or expansion stages, as well as clients needing TGA GMP audit response assistance and other regulatory affairs support including employee GMP training, CAPA and other quality management systems (QMS) to meet TGA’s regulatory standards and GMP or EU GMP.
Our consultants, architects, engineers and GMP course instructors and TGA GMP Audit response experts can assist clients from site selection through facility designs and processing systems, cleanrooms, validation across the lifecycle, workflow designs, as well as current PICS requirements including packaging and distribution (GMP/GDP and GxP requirements and employee training). Contact PharmOut for industry-specific facility architecture/processing designs, facility and validation engineering, GMP Audit response assistance and/or start-up, expansion and CAPA / QMS and technical writing assistance.
TGA approval and ARTG | TGA GMP Audit Responses
Products falling into the therapeutic goods category must be approved and registered by the TGA in the Australian Register of Therapeutic Goods (ARTG) before any manufacturer or supplier can supply or export those products to or from Australia.
Products must be registered by the TGA if they are:
- classed as ‘higher risk’ and have been assessed as meeting the requirements for quality, safety and efficacy and/or performance
- classed as a ‘lower risk’ medicine, biological or medical device application which has been validated.
The processes and requirements for each product’s approval as a therapeutic good varies across, and within, different categories of medicines and medical devices.
This variation is reflected in the different levels of quality documentation required to support each application and it can be tricky knowing which level of standard to comply to for each product.
We offer consulting services for companies wishing to register pharmaceutical, complementary medicine or dietary supplements with the Australian TGA, for sale within Australia, as well as GMP Audit Response expertise in a full range of consultancy to industries with GMP, EU GMP and PICS requirements.
PharmOut’s TGA and Regulatory Affairs consultancy services / TGA GMP Audit Responses support
Our TGA and Regulatory Affairs services / TGA GMP Audit Responses support services include, but are not limited to:
- regulatory strategy
- GMP audit response assistance including CAPA
- regulatory compliance for over the counter products
- regulatory compliance for prescription medicine
- regulatory compliance for product development
- regulatory compliance for medical devices
- reviewing chemistry/pharmacy, preclinical and clinical texts
- technical writing and preparation of the Common Technical Document (CTD)
- gap analysis, preparation and submission of the application to the TGA
- preparation of documents for clinical trial approval
- preparing marketing authorisation applications and submissions
- post-approval regulatory compliance
- submitting dossiers and paying fees on your behalf
For drug registrations, our TGA regulatory affairs consultants can assure validation of the dossier, receive questions from the TGA, and prepare suitable responses on your behalf. Our consultants can also co-ordinate the submission of responses and provide expert reports/overviews.
More Information about facility and process designs, including assistance with TGA approvals and/or GMP Audit Responses / TGA Audit Responses
Need help with your TGA Audit response (GMP Audit responses), TGA submissions, regulatory requirements, determining your product category, or just have a few questions you want to ask?
If you want to read more about TGA regulatory matters, why not have a look at our top 10 industry-specific blogs?
Page last updated on August 6, 2019. CM