Regulatory & Compliance Support

We understand the critical importance of adhering to regulatory standards, especially when it comes to the stringent requirements of the Therapeutic Goods Administration (TGA) and Food Standards Australia & New Zealand (FSANZ). Our Regulatory & Compliance Support services ensure your brand’s products meet all TGA standards, facilitating a smooth pathway to market approval and ongoing compliance.

Thorough Regulatory Compliance:

Navigating the complexities of the TGA and FSANZ regulations can be daunting. Our team of experts provide comprehensive guidance that ensure your products comply with all necessary standards.

Regulatory Strategy Development: Crafting a tailored strategy that aligns with your product goals and TGA and FSANZ requirements.
Regulatory Pathway identification: Identifying the most efficient regulatory pathway for your product, whether it’s a prescription medicine, over-the-counter (OTC) product, or complementary medicine.

TGA Submission Preparation:

We assist in the meticulous preparation of documentation required for TGA submissions, including:

Dossier Compilation: Compiling detailed and accurate dossiers that meet TGA standards, including technical, clinical and non-clinical data.
Application Preparation: Preparing and submitting applications for product registration, listing, or approval with the TGA.
Labelling Compliance: Ensuring product labels meet TGA requirements for content, format and claims.

Product Testing Validation:

Ensuring product safety and efficacy is paramount. We co-ordinate testing and validation processes to meet TGA standards.

Clinical Trials Co-ordination: Designing and managing clinical trials to generate necessary data for TGA submissions.
Quality Control Testing: Conducting rigorous quality control tests to ensure products meet safety and efficacy standards.
Stability Testing: Performing stability tests to determine the shelf-life and storage conditions of your products.

Ongoing Compliance Management:

Maintaining compliance post-approval is essential for continued market success. Our ongoing compliance services include:

Regulatory Updates: Keeping you informed of any changes in TGA regulations and advising on necessary adjustments to maintain compliance.
Product Monitoring: Monitoring products on the market to ensure they continue to meet TGA standards and managing any necessary reporting or recalls.
Audit Preparation: Preparing for TGA audits by conducting internal audits an addressing any potential issues proactively.

Documentation & Record-Keeping:

Accurate documentation and thorough record-keeping are crucial for regulatory compliance. Our services include:

Documentation Management: Managing all regulatory documents and ensuring they are up-to-date and easily accessible.
Record-Keeping Systems: Implementing robust record-keeping systems to track compliance activities and product histories.

Regulatory Affairs Liaison:

Brandverse acts as your liaison with the TGA, managing communications and ensuring a smooth regulatory process.

TGA Correspondence: Handling all communications with the TGA, including responding to queries and providing additional information as needed.
Representation: Representing your interests in discussions and negotiations with the TGA to facilitate timely approvals and resolve any regulatory issues.