REGULATORY & COMPLIANCE
Our clients are subject to unique regulatory hurdles specific to their industries. At FAL Lawyers, we’ve spent the last 20 years helping countless organisations with de-mystifying their compliance requirements, providing them with the certainty needed for them to get along with what they do best, whether it is developing new technology, providing healthcare services or rolling out their brands and ideas to new markets.
We have long experience in working with key regulators, including Consumer Affairs Victoria, ASIC, ACCC and the new Australian Charities and Not- for- profits Commission (ACNC).
Our team has also assisted with compliance with overseas regulations, including in the US and EU.
Our Regulatory & Compliance services include the following:
- Compliance with statutory and regulatory requirements
- Drafting and advice relating to Rules and Constitutions, stakeholder approval and related matters
- Ensuring all relevant documentation required by legislation is lodged with the respective Regulator
- Representing clients' interests with Regulators
- Compliance with Therapeutic Goods Administration (TGA) and US Food & Drug Authority (FDA) regulations
- Advice on regulations applicable to clinical trial agreements
FAL assisted a CRC spinoff biotechnology company developing polymers for use as corrective ocular implants regarding compliance with the US Food & Drug Authority (FDA) and CE regulations, leading to accreditation of the facility.
FAL consulted with the CRC Association on the potential impacts of the Defence Export Controls Bill (2011) on the R&D sector, assisted in the drafting of the Association’s submission to the Senate Committee reviewing the Bill prior to its enactment and met with the Chair of the Senate Committee as part of a delegation to express concerns on what may have been inadvertent restrictions in respect of the conduct of research in Australia.