Process Development and Scale-up: Design and optimize manufacturing processes to ensure scalability and regulatory compliance. This includes small-scale and large-scale production strategies, process validation, and technology transfer.
Analytical Method Development, Optimization, and Validation: Develop and validate robust analytical methods to ensure product quality, consistency, and regulatory compliance. This includes method optimization to improve efficiency and accuracy.
Manufacturing: Oversee all aspects of manufacturing, from production planning to execution, ensuring adherence to GMP standards. This includes the integration of automated systems, continuous process improvement, and cost-effective production strategies.

Clinical Operations: Manage and oversee all aspects of clinical trial execution, including site selection, patient recruitment, data management, and monitoring to ensure trials are conducted efficiently and in compliance with regulatory requirements.
Clinical Development: Guide the design and implementation of clinical trials, from early-stage studies to late-phase trials, with a focus on achieving regulatory approvals and supporting product claims.
Australian Clinical Trial Set-up and Rebate: Provide specialized support for setting up clinical trials in Australia, including navigating regulatory requirements and maximizing the R&D Tax Incentive rebate for eligible activities (up to 42.5%)

Regulatory Strategy and Submissions: Develop and execute regulatory strategies tailored to your product and market goals. Prepare and submit regulatory documents, including INDs, NDAs, and BLAs, to ensure compliance and expedite approvals.
Regulatory Compliance: Ensure ongoing compliance with all applicable regulations and standards through regular audits, risk assessments, and implementation of corrective actions.

CDMO Selection and Management: Identify and select the most suitable Contract Development and Manufacturing Organizations (CDMOs) to meet your project needs. Manage these relationships to ensure quality, timelines, and cost-effectiveness.
CRO Selection and Management: Select and oversee Clinical Research Organizations (CROs) to ensure that clinical trials are conducted with high quality and adherence to timelines and budgets.
Contract Negotiations: Negotiate contracts with vendors, ensuring that terms are favorable and aligned with your project objectives, including cost, timelines, and deliverables.