TGA Regulatory Affairs Consultants

TGA Regulatory Affairs Consultants

PharmOut’s TGA Regulatory Affairs Consultants can support you every step of the way to enable the supply of your products to the Australian market.

In addition to our registration services we offer a comprehensive range of services relating to general quality, validation and GMP consulting services. Assist with a set of downloadable quality management system templates for drugs and devices or we can write as much or as little of your QMS for you. We do focus on the importance of the underlying business processes, these must be optimal before turning them into repetitive procedures.

Our regulatory affairs services include:

  • regulatory strategy
  • regulatory compliance in product development
  • preparation of documents for clinical trial approval
  • preparation of documents and submissions for marketing regulatory approval
  • post-approval regulatory compliance

The agency responsible for regulating therapeutic products in Australia is the Therapeutic Goods Administration (TGA). The TGA framework for managing the vast range of products that come under the definition of therapeutic goods is pictured below.

Classification of products regulated by the Therapeutic Goods Administration: TGA-classification-of-products - TGA regulatory affairs consultants

The processes and requirements for product approval vary across and within the categories of medicines and devices, including the quality standards and documentation required to support an application.

Need help with TGA submission, regulatory requirements, or determining your product category, contact us?

Registering prescription medicines

PharmOut on supplies support for Australian TGA Drug Registration - Prescription Medicines undergo the highest level of regulation of all the medicines regulated by the Therapeutic Goods Adm ...

Registering OTC medicines

TGA registration of Over the Counter Medicines Over-the counter medicines (OTC) are medicines that are not prescription medicines and are not complementary medicines. Inclusion in the ARTG ...

Listing Complementary Medicines with the TGA

TGA listing of Complementary Medicines In Australia, complementary medicines include vitamin, mineral, herbal, aromatherapy and homoeopathic products.Products that may be considered to ...

Registering medical devices

Medical Device Registration TGA Australia We offer consulting services for Medical Device Registration TGA Australia to clients wishing to register medical devices with the Australian TGA, ...