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:
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?