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Compliance

Compliance is crucial in any business. Regulatory standards are strict and constantly evolving.

Ensuring that products, processes, and marketing activities meet legal and ethical guidelines not only helps safeguard public health but also strengthens brand reputation, reduces legal risks, and accelerates time to market. Non-compliance can lead to costly penalties, product recalls, and damage to a company's credibility.

Robust compliance processes and ongoing regulatory support are vital to maintaining the integrity and success of your business.

  • Regulatory Support: Assist in preparing regulatory submissions and liaise with regulatory authorities to ensure product approvals and ongoing compliance.

    Preparation and Submission of TGA Listing Applications: Manage the documentation and submission process for product listings with the Therapeutic Goods Administration (TGA).

    Liaising with the TGA: Maintain open communication with the TGA to address compliance issues and ensure alignment with regulations.

    Stability Advice and Protocol Development: Provide guidance on stability studies to meet regulatory standards.

  • Product Specifications Reviews: Evaluate and ensure that product specifications meet regulatory and organisational requirements.

    Ingredient and Product Formulation Reviews: Assess formulations to ensure compliance with regulatory guidelines and market standards.

    Product Claims / Therapeutic Indications Reviews and Evidence Packages: Review and substantiate product claims and therapeutic indications with robust evidence.

  • Advertising Compliance Reviews: Examine product promotional materials, including labels, packaging, brochures, display stands, and websites, to ensure they meet ethical and regulatory guidelines.

    Label Content Development and Reviews: Assist in creating and reviewing product labels to ensure compliance with regulations and accurate communication of information.

  • Compliance Training: Develop and deliver mandatory training programs to ensure adherence to regulatory and organisational standards.

    Ensure Ethical Standards: Oversee that all training activities and communications align with ethical principles and regulatory frameworks

  • Manufacturer Liaison and Recommendations: Work closely with manufacturers to ensure production processes meet compliance standards and provide expert recommendations.

    Product Development: Support the creation and refinement of products that comply with both regulatory and market requirements.

Contact us today to find out how we can tailor a package for your needs!