OPPORTUNA LEGAL

Contracts & Procurement Lawyers Australia  Clinical Trial Agreements & TGA Compliance  Opportuna Legal

 

Contracts & Procurement

 

From straightforward agreements to intricate, multifaceted contracts, Opportuna Legal provides comprehensive expertise to meet all your needs

 

Opportuna Legal provides expert advice on a wide range of contracts and procurement matters across Australia, including specialised clinical trial regulatory agreements and defence industry contracts. Based in Western Australia, we advise on and draft commercial contracts such as IT contracts, supply agreements, sale contracts, software agreements, and Clinical Trial Research Agreements (CTRAs). Our practical, commercially focused solutions are tailored to your business needs, with particular expertise in TGA compliance, clinical trial indemnity arrangements, and health data privacy under the Australian Privacy Principles.

 

Understanding the Tender Process in Australia

 

A tender process is a method of procurement often used by both business and government when procuring goods or services. The tender process is subject to complex legal issues because it involves a mix of contract law, administrative law and other commercial rules and regulations. Detailed procurement guidelines also apply to Commonwealth, State and Local Government procurements.

 

Expert Assistance with Tenders – Responding or Releasing

 

We can help if you are responding to a tender or releasing a tender. We have experience on both sides of the tender process and can assist your business in responding to an Expression of Interest (EOI), Request for Tender (RFT) or Request for Proposal (RFP).

 

We can assist with:

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• Assisting in the preparation of tender documents

• Acting as lead or support negotiator to negotiate the terms of contract

• Amending the contract or deed to reflect negotiated outcomes

• Advising on planning a tender to minimise risk

• Guidance through the selection process and the award of contracts

• Advising on responding to an RFP to meet your legal obligations

• Advising on obligations when managing suppliers at the conclusion of the tender process

 

Specialised Commercial Contract Drafting and Negotiation Services

 

In addition to tender-related work, we draft and negotiate a broad range of commercial contracts, including:

• Technology contracts, such as technology supply agreements, software development agreements, software licence agreements, cloud or software-as-a-service (SaaS) agreements, platform agreements, service level agreements (SLAs), and online privacy policies and terms and conditions

• Loan and other financial documentation, sale and supply contracts, and software agreements

• Construction contracts

• Consultant contracts

• Dispute resolution in contract and procurement matters

 

Clinical Trial Research Agreements (CTRAs) and Regulatory Compliance

Opportuna Legal offers specialised expertise in clinical trial regulatory matters for sponsors, CROs, research institutions, and biotech companies across Australia. We draft, review, and negotiate Clinical Trial Research Agreements (CTRAs) aligning with Therapeutic Goods Administration (TGA) requirements, ICH Good Clinical Practice (GCP) guidelines, and recent reforms.

 

Our services include:

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• Drafting and negotiating CTRAs for Phase I-IV trials, including multi-site and decentralised studies

• Advising on clinical trial indemnity arrangements and insurance obligations under NHMRC guidelines

• Ensuring privacy compliance for health data, including Australian Privacy Principles, GDPR alignment for cross-border trials, and risk management under recent privacy reforms

• Guidance on TGA compliance for therapeutic goods, medical devices, and AI in clinical trials

• Incorporating inclusivity requirements from MRFF/NHMRC reforms into ethical and participant clauses

• Strategic advice on IP protection, patentability, and regulatory pathways during trials

 

Defence Industry Contracts and ASDEFCON Compliance

 

Opportuna Legal provides expert guidance on defence contracts and procurement for suppliers, primes, and subcontractors across Australia. We navigate the complexities of the Australian Standard for Defence Contracting (ASDEFCON) suite, including tendering, compliance, and risk management. Our services support government and defence entities, ensuring alignment with Commonwealth procurement guidelines and strategic objectives.

 

Our services include:

• Responses to ASDEFCON tenders, including preparation of Statements of Non-Compliance, AIC plans, IP plans, and Confidential Information responses

• Assisting prime contractors with planning and managing supply chains, including preparing RFIs, RFQs, RFPs, RFTs, through-life support agreements, performance measures, and flow-downs from head contracts

• Advising tier 2 suppliers on contracting with larger defence primes, including contract reviews and negotiations

• Drafting and reviewing defence-related agreements, such as confidentiality, non-disclosure, and intellectual property licensing

• Guidance on aviation, aerospace, and technology regulatory issues, including drone regulations and engineering contracts

• Dispute resolution in defence procurement, including arbitration, mediation, and litigation support

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Opportuna Legal can provide you with strategic advice specific to your needs which is focused on securing the best outcome for you and your business—whether in general commercial contracts and procurement, tenders, technology agreements, or specialised clinical trial agreements and TGA regulatory compliance or defence industry contracts and ASDEFCON compliance.

 

Get in touch for tailored advice on tenders, commercial contract drafting, Clinical Trial Research Agreements, TGA compliance, ASDEFCON defence contracts,or any procurement and regulatory issue. Contact us today to discuss how we can support your business.